FDA product code FSO: Microscope, Surgical, General & Plastic Surgery
FSO is the FDA product code for microscope, surgical, general & plastic surgery. It is a Class I device, regulated under 21 CFR 878.4700 and reviewed by the General and Plastic Surgery panel. FDA has cleared 15 510(k) submissions under FSO, from 10 different applicants. The average 510(k) review took 112 days (median 43). FDA has posted 17 recalls for FSO devices, 8 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Microscope, Surgical, General & Plastic Surgery |
| Device class | Class I |
| Regulation | 21 CFR 878.4700 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FSO clearance
Top FSO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Jedmed Instrument Co. | 4 | 1993-10-12 |
| Moeller Microsurgical, Inc. | 2 | 1994-06-13 |
| Kelleher Corp. | 2 | 1982-08-27 |
| Appasamy Associates (U.S.A.), Inc. | 1 | 1994-04-22 |
| Deemed, Inc. | 1 | 1993-11-12 |
5 more applicants have FSO clearances. See the full list in Caduvo.
Most recent FSO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K942304 | Moeller Microsurgical, Inc. | MICROFLEX | 1994-06-13 | 31 |
| K941399 | Appasamy Associates (U.S.A.), Inc. | OPERATING MICROSCOPE AA OM 10 | 1994-04-22 | 31 |
| K920689 | Deemed, Inc. | DEEMED MSS -- MICROSCOPE SUPPORT SYSTEM | 1993-11-12 | 637 |
| K926288 | Jedmed Instrument Co. | SOM 6VI (SURGICAL OPERATING MICROSCOPE) | 1993-10-12 | 302 |
| K931303 | Woodlyn, Inc. | WOODLYN OPERATION MICROSCOPE | 1993-06-25 | 102 |
Recalls for FSO devices
17 product recalls in 12 recall events; 8 initiated in the last five years and 6 still open. Most recent: 2024-05-13.
| Year | Recalls |
|---|---|
| 2021 | 2 |
| 2022 | 5 |
| 2023 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code FSO?
FSO is the FDA product code for microscope, surgical, general & plastic surgery. It is a Class I device, regulated under 21 CFR 878.4700 and reviewed by the General and Plastic Surgery panel.
What device class is FSO?
Class I, regulation 21 CFR 878.4700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FSO?
Across 15 cleared submissions the average was 112 days from receipt to decision (median 43).
Which companies have the most FSO clearances?
Jedmed Instrument Co. (4); Moeller Microsurgical, Inc. (2); Kelleher Corp. (2); Appasamy Associates (U.S.A.), Inc. (1); Deemed, Inc. (1).
Have FSO devices been recalled?
Yes: 17 product recalls across 12 recall events; the most recent began 2024-05-13.
Next steps
- Run an FDA pathway report with predicate devices for product code FSO
- Run a recall and safety report across every FSO manufacturer
- Watch product code FSO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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