Odonto-Scope
FDA 510(k) K822562 · Treace Medical, Inc.
510(k) numberK822562
Submission
- Device name
- Odonto-Scope
- Applicant
- Treace Medical, Inc.
Mchenry, IL, US - Received
- August 24, 1982
- Decision date
- October 6, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FSO – Microscope, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4700
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FSO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K942304 | MicroflexFSO · Traditional | Moeller Microsurgical, Inc. | 06/13/1994SE |
| K941399 | Operating Microscope Aa Om 10FSO · Traditional | Appasamy Associates (U.S.A.), Inc. | 04/22/1994SE |
| K920689 | Deemed MSS -- Microscope Support SystemFSO · Traditional | Deemed, Inc. | 11/12/1993SE |
| K926288 | Som 6VI (Surgical Operating Microscope)FSO · Traditional | Jedmed Instrument Co. | 10/12/1993SE |
| K931303 | Woodlyn Operation MicroscopeFSO · Traditional | Woodlyn, Inc. | 06/25/1993SE |
| K926513 | Moller-Wedel Operating MicroscopeFSO · Traditional | Moeller Microsurgical, Inc. | 06/22/1993SE |
| K910357 | Som 6VFSO · Traditional | Jedmed Instrument Co. | 02/19/1991SE |
| K902076 | J2 MicroscopeFSO · Traditional | Jedmed Instrument Co. | 08/01/1990SE |
| K874241 | Opmi MD Surgical MicroscopeFSO · Traditional | Carl Zeiss, Inc. | 12/23/1987SE |
| K822181 | Binocular Oper. Microscopes & AccessorFSO · Traditional | Kelleher Corp. | 08/27/1982SE |
More from Kelleher Corp.
| 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 Odonto-Scope cleared by the FDA?
Odonto-Scope (K822562) received a 510(k) decision of Substantially Equivalent on October 6, 1982, 43 days after the submission was received.
What is the product code of K822562?
The FDA product code is FSO – Microscope, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4700.