FDA Product Code
FDA Product Code ETD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.3880
510(k) Clearances — 116 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252436 | Tula Tympanostomy Tube Delivery Device | Tusker Medical, Inc. | 2026-04-23 | Traditional | PDF ↗ |
| K250256 | Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) | Aventamed Dac | 2025-04-28 | Traditional | PDF ↗ |
| K232702 | Solo+ Tympanostomy Tube Device (TTD) | Aventamed Dac | 2024-05-20 | Traditional | PDF ↗ |
| K233658 | Biowy Tym Tube (TT) | Biowy Corporation | 2024-02-16 | Traditional | PDF ↗ |
| K232059 | Tympanostomy Tubes | Grace Medical, Inc. | 2023-11-24 | Traditional | PDF ↗ |
| K221254 | Hummingbird Tympanostomy Tube System | Preceptis Medical, Inc. | 2022-07-27 | Traditional | PDF ↗ |
| K200952 | Hummingbird Tympanostomy Tube System | Preceptis Medical, Inc. | 2020-06-05 | Traditional | PDF ↗ |
| K171239 | TULA Tube Delivery System | Tusker Medical | 2017-06-28 | Special | PDF ↗ |
| K151830 | Hummingbird Tympanostomy Tube | Preceptis Medical | 2015-09-21 | Traditional | PDF ↗ |
| K151067 | Ventilation (Tympanostomy) Tubes | Medtronic Xomed, Inc. | 2015-07-22 | Traditional | PDF ↗ |
| K142282 | HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS) | Preceptis Medical | 2015-04-23 | Traditional | PDF ↗ |
| K133921 | PRECEPTIS TYMPANOSTOMY TUBE INSERTER | Preceptis Medical | 2014-08-22 | Traditional | PDF ↗ |
| K103595 | ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM | Acclarent, Inc. | 2011-04-01 | Traditional | PDF ↗ |
| K082188 | TYMPANOSTOMY TUBE | Acclarent, Inc. | 2008-09-19 | Traditional | PDF ↗ |
| K071150 | TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE | Heinz Kurz GmbH Medizintechnik | 2007-12-12 | Traditional | PDF ↗ |
| K071178 | OTOMEDICS SOFT TYMPANOSTOMY TUBE | Otomedics Advanced Medical Technologies, Ltd. | 2007-06-22 | Traditional | PDF ↗ |
| K062672 | GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES | Grace Medical, Inc. | 2006-10-24 | Traditional | PDF ↗ |
| K062385 | BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES | Grace Medical, Inc. | 2006-09-27 | Traditional | PDF ↗ |
| K061058 | NEOZOLINE VENTILATION TUBES | Adept Medical, Ltd. | 2006-07-12 | Traditional | PDF ↗ |
| K011383 | MICRODOSE CATH, MODELS 90121-201, -202, -203 | Durect Corp. | 2001-06-25 | Special | PDF ↗ |
| K000801 | PC COATED FLUOROPLASTIC VENT TUBES | Gyrus Ent LLC | 2000-06-19 | Traditional | PDF ↗ |
| K991670 | SILVERSTEIN MICROWICK | Micromedics, Inc. | 1999-08-26 | Traditional | PDF ↗ |
| K992222 | FLUOROPLASTIC VENTILATION TUBES | Gyrus Ent LLC | 1999-08-26 | Traditional | PDF ↗ |
| K980828 | EXMOOR MYRINGOTOMY KIT | Exmoor Plastics , Ltd. | 1998-10-22 | Traditional | PDF ↗ |
| K981575 | TYMPANOSTOMY TUBE | Grace Medical, Inc. | 1998-07-15 | Traditional | PDF ↗ |
| K974008 | PFLEIDERER'S INTRATYMPANIC CATHETER | Exmoor Plastics , Ltd. | 1998-05-13 | Traditional | PDF ↗ |
| K973740 | ROUND WINDOW E-CATH | Neuro-Biometrix, Inc. | 1998-03-23 | Traditional | PDF ↗ |
| K974007 | SHAH PERMAVENT | Exmoor Plastics , Ltd. | 1997-12-12 | Traditional | PDF ↗ |
| K973226 | TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T) | Heinz Kurz GmbH Medizintechnik | 1997-11-04 | Traditional | PDF ↗ |
| K972126 | MYRINGOTOMY TUBE | Mednet Locator, Inc. | 1997-07-29 | Traditional | PDF ↗ |
| K972400 | MYRINGOTOMY TUBE - BOBBIN WITH TAB | Mednet Locator, Inc. | 1997-07-23 | Traditional | PDF ↗ |
| K971943 | MYRINGOTOMY TUBE | Mednet Locator, Inc. | 1997-07-23 | Traditional | PDF ↗ |
| K971454 | TYMPANOSTOMY VENTILATION TUBE | Ikonos Corp. | 1997-05-29 | Traditional | PDF ↗ |
| K971124 | TM MICRO-CATHETERS | Xomed, Inc. | 1997-05-16 | Traditional | PDF ↗ |
| K965115 | ROUND WINDOW CATH | Neuro-Biometrix, Inc. | 1997-03-10 | Traditional | PDF ↗ |
| K963727 | HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER | Medtronic Xomed | 1997-02-11 | Traditional | PDF ↗ |
| K961873 | ACTIVENT ANTIMICROBIAL VENTILATION TUBES | Xomed, Inc. | 1996-07-01 | Traditional | PDF ↗ |
| K961945 | TYMPANOSTOMY VENTILATION TUBE | Advanced Microbotics Corp. | 1996-06-11 | Traditional | PDF ↗ |
| K960742 | TYMPANOSTOMY VENTILATION TUBE | Advanced Microbotics Corp. | 1996-04-03 | Traditional | PDF ↗ |
| K960477 | VENTILATION TUBES | Smith & Nephew, Inc. | 1996-02-26 | Traditional | PDF ↗ |
| K955616 | MISTEN MEDICAL REUTER BOBBIN STYLE VENT TUBE | Misten Medical Corp. | 1996-01-17 | Traditional | PDF ↗ |
| K955447 | TYMPANOSTOMY TUBE | Trebay Medical Corp. | 1995-12-21 | Traditional | PDF ↗ |
| K954795 | AT2 & DOYLE STYLE (C-FLEX) VENT TUBES | Trebay Medical Corp. | 1995-11-15 | Traditional | PDF ↗ |
| K953802 | TYMPANOSTOMY TUBE | Bluff City Medical Technologies, Inc. | 1995-10-24 | Traditional | PDF ↗ |
| K953993 | TYMPASNOSTOMY TUBE | Hampton Precision Products, Inc. | 1995-09-12 | Traditional | PDF ↗ |
| K941407 | TYMPANOSTOMY (VENTILATION) TUBE | Xomed-Treace, Inc. | 1995-03-14 | Traditional | PDF ↗ |
| K943325 | TYMPANOSTOMY TUBE | Grace Medical, Inc. | 1994-10-11 | Traditional | PDF ↗ |
| K943848 | COLLAR BUTTON VENTURI VENT TUBE | Micromed Development Corp. | 1994-09-16 | Traditional | PDF ↗ |
| K943849 | GROMMENT STYLE VENTURI TUBE | Micromed Development Corp. | 1994-09-02 | Traditional | PDF ↗ |
| K943847 | BOBBIN STYLE VENTURI VENT TUBE | Micromed Development Corp. | 1994-09-02 | Traditional | PDF ↗ |
| K943190 | C-FLEX VENT TUBES | Micromed Development Corp. | 1994-08-24 | Traditional | PDF ↗ |
| K943281 | POLYETHYLENE VENT TUBES | Micromed Development Corp. | 1994-08-24 | Traditional | PDF ↗ |
| K936275 | TYMPOVENT | Atos Medical AB | 1994-05-05 | Traditional | PDF ↗ |
| K932166 | SILICONE TYMPANOSTOMY TUBES | Smith & Nephew Richards, Inc. | 1993-07-26 | Traditional | PDF ↗ |
| K923353 | VENTILATION TUBES W/ HYDROGEL COATING | Microbio-Medics, Inc. | 1993-05-18 | Traditional | PDF ↗ |
| K926462 | BEL-AIR VENTILATION TUBE | Exmoor Plastics , Ltd. | 1993-05-05 | Traditional | PDF ↗ |
| K923887 | JACK'S VENT TUBES | O.R. Specialties, Inc. | 1993-02-19 | Traditional | PDF ↗ |
| K921923 | TITANIUM VENTILATION TUBES | Exmoor Plastics , Ltd. | 1993-02-12 | Traditional | PDF ↗ |
| K911580 | DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-MINI TUBES | Exmoor Plastics , Ltd. | 1991-09-24 | Traditional | PDF ↗ |
| K910618 | SUH VENT TUBE | Boston Medical Products, Inc. | 1991-06-28 | Traditional | PDF ↗ |
| K904592 | BOBBIN STYLE VENTURI | River Medical, Inc. | 1991-01-28 | Traditional | PDF ↗ |
| K904597 | GROMMET STYLE VENTURI | River Medical, Inc. | 1991-01-28 | Traditional | PDF ↗ |
| K904594 | COLLAR BUTTON STYLE VENTURI | River Medical, Inc. | 1991-01-28 | Traditional | PDF ↗ |
| K903285 | MICRO BRIGHT VENTILATION TUBES | Invotec International, Inc. | 1990-09-26 | Traditional | PDF ↗ |
| K900267 | JAHN VENTILATION TUBE | Smith & Nephew Richards, Inc. | 1990-06-14 | Traditional | PDF ↗ |
| K895242 | PAPPAS TRI-FLANGE VENTILATION TUBE | Richards Medical Co., Inc. | 1989-11-17 | Traditional | PDF ↗ |
| K883667 | DONALDSON VENTILATION TUBES PT. # AG/S9 | Exmoor Plastics , Ltd. | 1988-11-14 | Traditional | PDF ↗ |
| K882689 | PUNCH MYRINGOTOMY SYSTEM | Xomed, Inc. | 1988-09-13 | Traditional | PDF ↗ |
| K870877 | BIO-VENT REUTER BOBBIN TUBE | Richards Medical Co., Inc. | 1987-03-26 | Traditional | PDF ↗ |
| K871035 | 'EXMOOR' T-TUBE | Exmoor Plastics , Ltd. | 1987-03-23 | Traditional | PDF ↗ |
| K870129 | VENTILATION TUBES WITH HYDROGEL COATING | Richards Medical Co., Inc. | 1987-02-10 | Traditional | PDF ↗ |
| K852387 | GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE | Xomed, Inc. | 1986-01-06 | Traditional | PDF ↗ |
| K853641 | GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE | Xomed, Inc. | 1986-01-06 | Traditional | PDF ↗ |
| K833246 | TYMPANOSTOMY TUBES-VARIOUS | Abco Dealers, Inc. | 1985-01-04 | Traditional | PDF ↗ |
| K842637 | UNIFLOW VENT TUBE | Richards Medical Co., Inc. | 1984-10-25 | Traditional | PDF ↗ |
| K823910 | DONALDSON VENT TUBE | Treace Medical, Inc. | 1983-11-22 | Traditional | PDF ↗ |
| K833910 | TSH RIA | Syncor Intl. Corp. | 1983-11-22 | Traditional | PDF ↗ |
| K833909 | VENTRESCREEN BETA-HCG ENZYME IMMUNO | Vxr, Inc. | 1983-11-21 | Traditional | PDF ↗ |
| K832362 | DONALDSON-TYPE VENT TUBE | Concept, Inc. | 1983-10-14 | Traditional | PDF ↗ |
| K832361 | CONCEPT T-TUBE | Concept, Inc. | 1983-10-14 | Traditional | PDF ↗ |
| K830584 | SOILEAU TYTAN BOBBIN VENT TUBE | Treace Medical, Inc. | 1983-06-02 | Traditional | PDF ↗ |
| K823909 | T-TUBE VENT TUBE | Treace Medical, Inc. | 1983-03-17 | Traditional | PDF ↗ |
| K830228 | OTOLOGICAL VENTILATION TUBES-VARIOUS | Micromedics, Inc. | 1983-03-07 | Traditional | PDF ↗ |
| K823908 | GROMMET VENT TUBE | Treace Medical, Inc. | 1983-01-28 | Traditional | PDF ↗ |
| K823907 | COLLAR BUTTON VENT TUBE | Treace Medical, Inc. | 1983-01-28 | Traditional | PDF ↗ |
| K830085 | COLLAR BUTTON VENT TUBE | Treace Medical, Inc. | 1983-01-28 | Traditional | PDF ↗ |
| K822017 | TYMPANOSTOMY TUBES & VARIOUS TYPES | Kelleher Corp. | 1982-10-27 | Traditional | PDF ↗ |
| K822375 | ARMSTRONG V VENT TUBE | Treace Medical, Inc. | 1982-09-09 | Traditional | PDF ↗ |
| K822376 | TYTAN REUTER BOBBIN VENT TUBE | Treace Medical, Inc. | 1982-09-09 | Traditional | PDF ↗ |
| K822366 | TYTAN GROMMET VENT TUBE, .040 | Treace Medical, Inc. | 1982-09-02 | Traditional | PDF ↗ |
| K820510 | TYMPANOSTOMY TUBES (VARIOUS MODELS | Abco Dist. | 1982-03-19 | Traditional | PDF ↗ |
| K820362 | REUTER BOBBIN VENTILA. TUBE-TITANIUM | Richard'S Medical Equip., Inc. | 1982-03-02 | Traditional | PDF ↗ |
| K813616 | TEKNA MED MYRINGOTOMY DISPOS-OTO KIT | Humboldt Products | 1982-01-22 | Traditional | PDF ↗ |
| K812459 | EXMOOR AURAL GROMMET AG/TI | Exmoor Plastics , Ltd. | 1981-09-25 | Traditional | PDF ↗ |
| K812460 | VARIOUS AURAL GROMMETS | Exmoor Plastics , Ltd. | 1981-09-21 | Traditional | PDF ↗ |
| K811698 | CARL ZEISS INN MYRINGOTOMY TUBE LINE | James L. Geraci & Associates, Inc. | 1981-08-31 | Traditional | PDF ↗ |
| K810702 | EXMOOR AURAL GROMMET AG/T2L | Exmoor Plastics , Ltd. | 1981-04-14 | Traditional | PDF ↗ |
| K810703 | EXMOOR AURAL GROMMET AG/T2 | Exmoor Plastics , Ltd. | 1981-04-14 | Traditional | PDF ↗ |
| K810705 | EXMOOR AURAL GROMMET AG/T4 | Exmoor Plastics , Ltd. | 1981-04-14 | Traditional | PDF ↗ |
| K810704 | EXMOOR AURAL GROMMET AG/T3 | Exmoor Plastics , Ltd. | 1981-04-14 | Traditional | PDF ↗ |
Product code ETD · Class II · Ear, Nose, Throat. Data: openFDA.