MICROFLEX
FDA 510(k) clearance K942304 · decided 1994-06-13
Clearance details
- K-number
- K942304
- Device name
- MICROFLEX
- Applicant
- Moeller Microsurgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-05-13
- Decision date
- 1994-06-13
- Days to decision
- 31 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
- Waldwick, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Moeller Microsurgical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
| OPMI MD SURGICAL MICROSCOPE (K874241) | Carl Zeiss, Inc. | 1987-12-23 |
| 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.