Som 6VI (Surgical Operating Microscope)
FDA 510(k) K926288 · Jedmed Instrument Co.
510(k) numberK926288
Submission
- Device name
- Som 6VI (Surgical Operating Microscope)
- Applicant
- Jedmed Instrument Co.
St.Louis, MO, US - Received
- December 14, 1992
- Decision date
- October 12, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K822562 | Odonto-ScopeFSO · Traditional | Treace Medical, Inc. | 10/06/1982SE |
| K822181 | Binocular Oper. Microscopes & AccessorFSO · Traditional | Kelleher Corp. | 08/27/1982SE |
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| K950785 | Hortmann Airmatic Air Caloric StimulatorKHH · Traditional | 06/28/1995SE |
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Questions and answers
When was Som 6VI (Surgical Operating Microscope) cleared by the FDA?
Som 6VI (Surgical Operating Microscope) (K926288) received a 510(k) decision of Substantially Equivalent on October 12, 1993, 302 days after the submission was received.
What is the product code of K926288?
The FDA product code is FSO – Microscope, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4700.