FDA 510(k) Applications Submitted by Umesh Sharma
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K200166 |
01/22/2020 |
Mirus Ligating Clip, Mirus Ligating Clip Applier |
M/s. Meril Endo Surgery Private Limited |
| K200320 |
02/07/2020 |
Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload |
M/s. Meril Endo Surgery Private Limited |
| K200452 |
02/24/2020 |
Meril-Bonewax |
M/s. Meril Endo Surgery Private Limited |
| K160623 |
03/04/2016 |
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture |
M/S. MERIL ENDO SURGERY PRIVATE LIMITED |
| K150717 |
03/19/2015 |
Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron |
M/s. Meril Endo Surgery Private Limited |
| K160771 |
03/21/2016 |
Destiknee Total Knee System |
MERIL HEALTHCARE PRIVATE LIMITED |
| K230981 |
04/05/2023 |
Meriglu Topical Skin Adhesive |
M/s Meril Endo Surgery Private Limited |
| K171320 |
05/04/2017 |
ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, AR |
Meril Healthcare Pvt. Ltd. |
| K231818 |
06/21/2023 |
METICÖ- Airway Balloon Catheter |
M/s Meril Life Sciences Pvt. Ltd. |
| K172146 |
07/17/2017 |
MERISTEEL |
M/s. Meril Endo Surgery Private Limited |
| K172149 |
07/17/2017 |
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture |
M/s. Meril Endo Surgery Private Limited |
| K232246 |
07/28/2023 |
1) PINIONÖ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINIONÖ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture |
M/s. Meril Endo Surgery Private Limited |
| K172659 |
09/05/2017 |
MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(gly |
M/s. Meril Endo Surgery Private Limited |
| K172737 |
09/11/2017 |
MESIRE - Balloon Sinus Dilatation System |
M/s. Meril Life Sciences Private Limited |
| K233386 |
10/02/2023 |
MonikÖ - Disposable Endoscopic Trocar |
M/s. Meril Endo Surgery Private Limited. |
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