FDA 510(k) Applications for Medical Device Product Code "ETD"
(Tube, Tympanostomy)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K103595 | ACCLARENT, INC. | ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM | 04/01/2011 |
| K082188 | ACCLARENT, INC. | TYMPANOSTOMY TUBE | 09/19/2008 |
| K061058 | ADEPT MEDICAL LTD | NEOZOLINE VENTILATION TUBES | 07/12/2006 |
| K960742 | ADVANCED MICROBOTICS CORP. | TYMPANOSTOMY VENTILATION TUBE | 04/03/1996 |
| K961945 | ADVANCED MICROBOTICS CORP. | TYMPANOSTOMY VENTILATION TUBE | 06/11/1996 |
| K011383 | DURECT CORP. | MICRODOSE CATH, MODELS 90121-201, -202, -203 | 06/25/2001 |
| K980828 | EXMOOR PLASTICS LTD. | EXMOOR MYRINGOTOMY KIT | 10/22/1998 |
| K974008 | EXMOOR PLASTICS LTD. | PFLEIDERER'S INTRATYMPANIC CATHETER | 05/13/1998 |
| K974007 | EXMOOR PLASTICS LTD. | SHAH PERMAVENT | 12/12/1997 |
| K062385 | Grace Medical, Inc. | BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES | 09/27/2006 |
| K062672 | Grace Medical, Inc. | GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES | 10/24/2006 |
| K981575 | Grace Medical, Inc. | TYMPANOSTOMY TUBE | 07/15/1998 |
| K992222 | GYRUS ENT L.L.C. | FLUOROPLASTIC VENTILATION TUBES | 08/26/1999 |
| K000801 | GYRUS ENT L.L.C. | PC COATED FLUOROPLASTIC VENT TUBES | 06/19/2000 |
| K071150 | HEINZ KURZ GMBH MEDIZINTECHNIK | TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE | 12/12/2007 |
| K973226 | HEINZ KURZ GMBH MEDIZINTECHNIK | TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T) | 11/04/1997 |
| K971454 | IKONOS CORP. | TYMPANOSTOMY VENTILATION TUBE | 05/29/1997 |
| K971943 | MEDNET LOCATOR, INC. | MYRINGOTOMY TUBE | 07/23/1997 |
| K972126 | MEDNET LOCATOR, INC. | MYRINGOTOMY TUBE | 07/29/1997 |
| K972400 | MEDNET LOCATOR, INC. | MYRINGOTOMY TUBE - BOBBIN WITH TAB | 07/23/1997 |
| K963727 | MEDTRONIC XOMED | HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER | 02/11/1997 |
| K151067 | Medtronic Xomed, Inc. | Ventilation (Tympanostomy) Tubes | 07/22/2015 |
| K991670 | MICROMEDICS, INC. | SILVERSTEIN MICROWICK | 08/26/1999 |
| K955616 | MISTEN MEDICAL CORP. | MISTEN MEDICAL REUTER BOBBIN STYLE VENT TUBE | 01/17/1996 |
| K965115 | NEURO-BIOMETRIX, INC. | ROUND WINDOW CATH | 03/10/1997 |
| K973740 | NEURO-BIOMETRIX, INC. | ROUND WINDOW E-CATH | 03/23/1998 |
| K071178 | OTOMEDICS ADVANCED MEDICAL TECHNOLOGIES, LTD. | OTOMEDICS SOFT TYMPANOSTOMY TUBE | 06/22/2007 |
| K151830 | PRECEPTIS MEDICAL | Hummingbird Tympanostomy Tube | 09/21/2015 |
| K142282 | PRECEPTIS MEDICAL | HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS) | 04/23/2015 |
| K133921 | PRECEPTIS MEDICAL | PRECEPTIS TYMPANOSTOMY TUBE INSERTER | 08/22/2014 |
| K200952 | Preceptis Medical, Inc | Hummingbird Tympanostomy Tube System | 06/05/2020 |
| K221254 | Preceptis Medical, Inc. | Hummingbird Tympanostomy Tube System | 07/27/2022 |
| K960477 | SMITH & NEPHEW, INC. | VENTILATION TUBES | 02/26/1996 |
| K171239 | Tusker Medical | TULA Tube Delivery System | 06/28/2017 |
| K961873 | XOMED, INC. | ACTIVENT ANTIMICROBIAL VENTILATION TUBES | 07/01/1996 |
| K971124 | XOMED, INC. | TM MICRO-CATHETERS | 05/16/1997 |
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