FDA 510(k) Applications Submitted by ETHICON ENDO-SURGERY, LLC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K081146 |
04/22/2008 |
ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT) |
ETHICON ENDO-SURGERY, LLC |
| K092577 |
08/21/2009 |
ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75) |
ETHICON ENDO-SURGERY, LLC |
| K140560 |
03/05/2014 |
ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING |
ETHICON ENDO-SURGERY, LLC |
| K121600 |
06/01/2012 |
ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE |
ETHICON ENDO-SURGERY, LLC |
| K112056 |
07/19/2011 |
ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL |
ETHICON ENDO-SURGERY, LLC |
| K093899 |
12/18/2009 |
MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING |
ETHICON ENDO-SURGERY, LLC |
| K132612 |
08/21/2013 |
HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE |
ETHICON ENDO-SURGERY, LLC |
| K133314 |
10/28/2013 |
HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY |
ETHICON ENDO-SURGERY, LLC |
| K180031 |
01/04/2018 |
Endopath Electrosurgery Probe Plus II |
Ethicon Endo-Surgery, LLC |
| K172580 |
08/28/2017 |
ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, |
Ethicon Endo-Surgery, LLC |
| K163454 |
12/09/2016 |
ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm |
ETHICON ENDO-SURGERY, LLC |
| K163523 |
12/15/2016 |
ECHELON CIRCULAR Powered Stapler |
Ethicon Endo-Surgery, LLC |
| K130653 |
03/12/2013 |
ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU |
ETHICON ENDO-SURGERY, LLC |
| K131663 |
06/07/2013 |
ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK |
ETHICON ENDO-SURGERY, LLC |
| K160554 |
02/29/2016 |
Enseal X1 Large Jaw Tissue Sealer |
ETHICON ENDO-SURGERY, LLC |
| K132512 |
08/12/2013 |
HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE |
ETHICON ENDO-SURGERY, LLC |
| K132522 |
08/12/2013 |
HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE |
ETHICON ENDO-SURGERY, LLC |
| K110049 |
01/07/2011 |
REUSABLE LINEAR STAPLER HANDLE |
ETHICON ENDO-SURGERY, LLC |
| K070887 |
03/30/2007 |
ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS) |
ETHICON ENDO-SURGERY, LLC |
| K062209 |
08/01/2006 |
BASX BLADELESS TROCAR |
ETHICON ENDO-SURGERY, LLC |
| K062869 |
09/25/2006 |
CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS CS40B, CS40G, CR40B AND CR40G |
ETHICON ENDO-SURGERY, LLC |
| K103672 |
12/16/2010 |
REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET |
ETHICON ENDO-SURGERY, LLC |
| K120729 |
03/09/2012 |
HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23 |
ETHICON ENDO-SURGERY, LLC |
| K230387 |
02/14/2023 |
ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S) |
Ethicon Endo-Surgery, LLC |
| K072203 |
08/08/2007 |
HARMONIC 10CM COMBINATION HOOK BLADE |
ETHICON ENDO-SURGERY, LLC |
| K063192 |
10/20/2006 |
HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIP |
ETHICON ENDO-SURGERY, LLC |
| K061192 |
04/28/2006 |
BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXAMINATION GLOVES |
ETHICON ENDO-SURGERY, LLC |
| K123141 |
10/05/2012 |
ENSEAL TRIO TISSUE SEALING DEVICE |
ETHICON ENDO-SURGERY, LLC |
| K141122 |
04/30/2014 |
HARMONIC SCALLOP BLADE, GENERATOR G11 |
ETHICON ENDO-SURGERY, LLC |
| K122511 |
08/17/2012 |
ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH |
ETHICON ENDO-SURGERY, LLC |
| K122797 |
09/12/2012 |
ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAW |
ETHICON ENDO-SURGERY, LLC |
| K070151 |
01/16/2007 |
INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER |
ETHICON ENDO-SURGERY, LLC |
| K111111 |
04/20/2011 |
ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO |
ETHICON ENDO-SURGERY, LLC |
| K123212 |
10/15/2012 |
ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS |
ETHICON ENDO-SURGERY, LLC |
| K100597 |
03/02/2010 |
HARMONIC FOCUS SHEARS |
ETHICON ENDO-SURGERY, LLC |
| K121550 |
05/25/2012 |
HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY |
ETHICON ENDO-SURGERY, LLC |
| K131435 |
05/20/2013 |
ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW, |
ETHICON ENDO-SURGERY, LLC |
| K160128 |
01/20/2016 |
Endopath Electrosurgery Probe Plus II |
Ethicon Endo-Surgery, LLC |
| K160521 |
02/25/2016 |
ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm |
ETHICON ENDO-SURGERY, LLC |
| K150840 |
03/30/2015 |
Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier |
ETHICON ENDO-SURGERY, LLC |
| K151136 |
04/29/2015 |
HARMONIC HOOK |
ETHICON ENDO-SURGERY, LLC |
| K151340 |
05/19/2015 |
HARMONIC Focus Long Shears + Adaptive Tissue Technology |
ETHICON ENDO-SURGERY, LLC |
| K163548 |
12/16/2016 |
ENSEAL X1 Large Jaw Tissue Sealer |
Ethicon Endo-Surgery, LLC |
| K200420 |
02/20/2020 |
Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green |
Ethicon Endo-Surgery, LLC |
| K200841 |
03/31/2020 |
Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 |
Ethicon Endo-Surgery, Llc |
| K201066 |
04/22/2020 |
ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length |
Ethicon Endo-Surgery, LLC |
| K211273 |
04/27/2021 |
Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray |
Ethicon Endo-Surgery, LLC |
| K191555 |
06/12/2019 |
HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length |
Ethicon Endo-Surgery, LLC |
| K221790 |
06/21/2022 |
HARMONIC 700 Shears |
Ethicon Endo-Surgery, LLC |
| K201696 |
06/22/2020 |
ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length |
Ethicon Endo-Surgery, LLC |
| K202665 |
09/14/2020 |
Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm |
Ethicon Endo-Surgery, LLC |
| K213633 |
11/17/2021 |
ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler |
Ethicon Endo-Surgery, LLC |
| K080839 |
03/25/2008 |
ECHELON GRAY CARTRIDGE, MODEL ERC45M |
ETHICON ENDO-SURGERY, LLC |
| K180403 |
02/14/2018 |
ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length |
Ethicon Endo-Surgery, LLC |
| K181488 |
06/06/2018 |
LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier |
Ethicon Endo-Surgery, LLC |
| K181653 |
06/22/2018 |
Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed |
Ethicon Endo-Surgery, LLC |
| K183435 |
12/11/2018 |
Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black |
Ethicon Endo-Surgery, LLC |
| K070198 |
01/22/2007 |
ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES AND ENDOPATH DEXTRUS FIXED-LENGTH ACCESS RETRACTORS, HAP02 |
ETHICON ENDO-SURGERY, LLC |
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