Mirror Tip
FDA 510(k) K823915 · Treace Medical, Inc.
510(k) numberK823915
Submission
- Device name
- Mirror Tip
- Applicant
- Treace Medical, Inc.
Walker, MI, US - Received
- December 28, 1982
- Decision date
- January 21, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KAI – Mirror, Ent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code KAI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K833601 | Antrum & Attic MirrorKAI · Traditional | Microtek Medical, Inc. | 01/03/1984SE |
| K822374 | Buckingham Attic & Antrum MirrorKAI · Traditional | Treace Medical, Inc. | 09/09/1982SE |
| K822261 | Laryngeal MirrorsKAI · Traditional | Kelleher Corp. | 08/30/1982SE |
| K822191 | Head Mirror with HeadbandKAI · Traditional | Kelleher Corp. | 08/20/1982SE |
| K820354 | Atmos Mirror WarmerKAI · Traditional | Jedmed Instrument Co. | 03/01/1982SE |
| K781750 | Mirror WarmerKAI · Traditional | Arleton Technical Products, Inc. | 01/17/1979SE |
| K770054 | Mirror, Naso-PharynxKAI · Traditional | Welch Allyn, Inc. | 01/18/1977SE |
| K770053 | Mirror, LaryngealKAI · Traditional | Welch Allyn, Inc. | 01/18/1977SE |
More from Welch Allyn, 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 Mirror Tip cleared by the FDA?
Mirror Tip (K823915) received a 510(k) decision of Substantially Equivalent on January 21, 1983, 24 days after the submission was received.
What is the product code of K823915?
The FDA product code is KAI – Mirror, Ent, a Class I (low risk) device regulated under 21 CFR 874.4420.