510(k) K973740
- Device
- ROUND WINDOW E-CATH
- Applicant
- NEURO-BIOMETRIX, INC.
- 510(k) number
- K973740
- Product code
- ETD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-03-23
- Date received
- 1997-10-01
- Regulation
- 874.3880
- Classification name
- Tube, Tympanostomy
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL H ARENBERG
- Address
- 7995 E. Prentice Ave. Englewood CO US 80111 80111
FDA Registration Numbers#
- 3010155661
- 3024021261
- 3013233645
- 3002807315
- 3017636737
- 1926681
- 1317188
- 2183744
- 3016678045
- 3012112259
- 3002806953
- 8010617
- 1519132
- 3012266672
- 3010610937
- 1057421
- 3003790304
- 3009217531
- 3010487482
- 1037007
- 3012130335
- 1052728
- 3005255160
- 3011050570
- 3010132111
- 9612501
- 3018094310
- 1048735
- 3012494290
- 3006098219
- 3013557562
- 3003678543
- 1045254
- 1928237
- 3043226252
- 3008719017
Source Documents#
Other 510(k) Records For Product Code ETD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252436 | Tula Tympanostomy Tube Delivery Device | Tusker Medical, Inc. | 2026-04-23 |
| 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 |
| K232702 | Solo+ Tympanostomy Tube Device (TTD) | Aventamed Dac | 2024-05-20 |
| K233658 | Biowy Tym Tube (TT) | Biowy Corporation | 2024-02-16 |
| K232059 | Tympanostomy Tubes | Grace Medical, Inc. | 2023-11-24 |
| K221254 | Hummingbird Tympanostomy Tube System | Preceptis Medical, Inc. | 2022-07-27 |
| K200952 | Hummingbird Tympanostomy Tube System | Preceptis Medical, Inc. | 2020-06-05 |
| K171239 | TULA Tube Delivery System | Tusker Medical | 2017-06-28 |
| K151830 | Hummingbird Tympanostomy Tube | Preceptis Medical | 2015-09-21 |
| K151067 | Ventilation (Tympanostomy) Tubes | Medtronic Xomed, Inc. | 2015-07-22 |
| K142282 | HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS) | Preceptis Medical | 2015-04-23 |
| K133921 | PRECEPTIS TYMPANOSTOMY TUBE INSERTER | Preceptis Medical | 2014-08-22 |
| K103595 | ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM | Acclarent, Inc. | 2011-04-01 |
| K082188 | TYMPANOSTOMY TUBE | Acclarent, Inc. | 2008-09-19 |
| 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 |
Legacy Summary#
summary
FDA Review#
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