OPMI MD SURGICAL MICROSCOPE
FDA 510(k) clearance K874241 · decided 1987-12-23
Clearance details
- K-number
- K874241
- Device name
- OPMI MD SURGICAL MICROSCOPE
- Applicant
- Carl Zeiss, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-10-15
- Decision date
- 1987-12-23
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- FSO
- Device class
- 1
- Regulation number
- 878.4700
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Thornwood, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MICROFLEX (K942304) | Moeller Microsurgical, Inc. | 1994-06-13 |
| OPERATING MICROSCOPE AA OM 10 (K941399) | Appasamy Associates (U.S.A.), Inc. | 1994-04-22 |
| DEEMED MSS -- MICROSCOPE SUPPORT SYSTEM (K920689) | Deemed, Inc. | 1993-11-12 |
| SOM 6VI (SURGICAL OPERATING MICROSCOPE) (K926288) | Jedmed Instrument Co. | 1993-10-12 |
| WOODLYN OPERATION MICROSCOPE (K931303) | Woodlyn, Inc. | 1993-06-25 |
| MOLLER-WEDEL OPERATING MICROSCOPE (K926513) | Moeller Microsurgical, Inc. | 1993-06-22 |
| SOM 6V (K910357) | Jedmed Instrument Co. | 1991-02-19 |
| J2 MICROSCOPE (K902076) | Jedmed Instrument Co. | 1990-08-01 |
| ODONTO-SCOPE (K822562) | Treace Medical, Inc. | 1982-10-06 |
| BINOCULAR OPER. MICROSCOPES & ACCESSOR (K822181) | Kelleher Corp. | 1982-08-27 |
| BINOCULAR OPERATING MICROSCOPES AND (K822015) | Kelleher Corp. | 1982-07-30 |
| FMS-02 FLOOR-UNIT MODEL MICROSCOPE (K802713) | Jedmed Instrument Co. | 1980-11-19 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VISULAS ND:YAG LASER (P850083/S008) | Carl Zeiss, Inc. | 1989-08-02 |
| VISULAS ND:YAG LASER (P850083/S007) | Carl Zeiss, Inc. | 1988-07-15 |
| VISULAS ND:YAG LASER (P850083/S006) | Carl Zeiss, Inc. | 1987-10-05 |
| VISULAS ND:YAG LASER (P850083/S005) | Carl Zeiss, Inc. | 1987-09-30 |
| VISULAS ND:YAG LASER (P850083/S004) | Carl Zeiss, Inc. | 1987-03-31 |
| VISULAS ND:YAG LASER (P850083/S001) | Carl Zeiss, Inc. | 1987-03-10 |
| VISULAS ND:YAG LASER (P850083/S003) | Carl Zeiss, Inc. | 1986-12-04 |