Right Angled Pick
FDA 510(k) K841355 · Treace Medical, Inc.
510(k) numberK841355
Submission
- Device name
- Right Angled Pick
- Applicant
- Treace Medical, Inc.
Mchenry, IL, US - Received
- April 2, 1984
- Decision date
- July 3, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JYT – Pick, Microsurgical Ear
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code JYT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K822176 | Microsurgical Ear PicksJYT · Traditional | Kelleher Corp. | 08/16/1982SE |
More from Kelleher Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K883727 | Bucket Prosthesis PorpETB · Traditional | 01/13/1989SE |
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| 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 Right Angled Pick cleared by the FDA?
Right Angled Pick (K841355) received a 510(k) decision of Substantially Equivalent on July 3, 1984, 92 days after the submission was received.
What is the product code of K841355?
The FDA product code is JYT – Pick, Microsurgical Ear, a Class I (low risk) device regulated under 21 CFR 874.4420.