Micro & Mini-Micro Alligator Forceps
FDA 510(k) K822369 · Treace Medical, Inc.
510(k) numberK822369
Submission
- Device name
- Micro & Mini-Micro Alligator Forceps
- Applicant
- Treace Medical, Inc.
Mchenry, IL, US - Received
- August 6, 1982
- Decision date
- September 9, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KAE – Forceps, Ent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code KAE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K853708 | Laryngascopes, Forceps, Micro Suction Tube & RefleKAE · Traditional | Downs Surgical , Ltd. | 02/14/1986SE |
| K851795 | 41-250 to 41-282 Various Nasal Cutting ForcepsKAE · Traditional | Artiberia | 06/11/1985SE |
| K851794 | 41-180 to 41-246 Various Nasal ForcepsKAE · Traditional | Artiberia | 06/11/1985SE |
| K851775 | 19-790 to 19-1042 Dressing/Sponge ForcepsKAE · Traditional | Artiberia | 06/11/1985SE |
| K833608 | Gold Alligator ForcepsKAE · Traditional | Microtek Medical, Inc. | 01/11/1984SE |
| K833607 | Mcgee ForcepsKAE · Traditional | Microtek Medical, Inc. | 01/03/1984SE |
| K833605 | Cupped ForcepsKAE · Traditional | Microtek Medical, Inc. | 01/03/1984SE |
| K822372 | Office Econo-ForcepsKAE · Traditional | Treace Medical, Inc. | 09/09/1982SE |
| K812895 | Yarmo Nasal Cartilage SoftenerKAE · Traditional | American V. Mueller | 11/02/1981SE |
| K772398 | Cottle Lower Lateral ForcepsKAE · Traditional | Edward Weck, Inc. | 01/17/1978SE |
More from Edward Weck, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883727 | Bucket Prosthesis PorpETB · Traditional | 01/13/1989SE |
| K882349 | Mallet, SurgicalHXL · Traditional | 06/23/1988SE |
| K874779 | Bipolator 50GEI · Traditional | 01/29/1988SE |
| K873154 | Treace Magnum Oto-Tool SystemERL · Traditional | 09/04/1987SE |
| K872000 | Eye GardHOY · Traditional | 07/21/1987SE |
| K870765 | Cannulated Instrument CleanersEKW · Traditional | 05/27/1987SE |
| K871706 | Optha PrepHMT · Traditional | 05/18/1987SE |
| K870759 | Cleaning Solution, Catalog No. 8203LRJ · Traditional | 05/07/1987SE |
| K870766 | Prosthesis WireETB · Traditional | 04/15/1987SE |
| K870764 | Schuknecht Wire Cutting Scissors · Traditional | 03/18/1987SE |
Questions and answers
When was Micro & Mini-Micro Alligator Forceps cleared by the FDA?
Micro & Mini-Micro Alligator Forceps (K822369) received a 510(k) decision of Substantially Equivalent on September 9, 1982, 34 days after the submission was received.
What is the product code of K822369?
The FDA product code is KAE – Forceps, Ent, a Class I (low risk) device regulated under 21 CFR 874.4420.