FDA product code FZS: Curette, Surgical, General Use
FZS is the FDA product code for curette, surgical, general use. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 14 510(k) submissions under FZS, from 13 different applicants. The average 510(k) review took 46 days (median 26). FDA has posted 3 recalls for FZS devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Curette, Surgical, General Use |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| 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 FZS clearance
Top FZS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Euro-Med Intl. | 2 | 1985-12-24 |
| Whitney Products, Inc. | 1 | 1994-01-07 |
| Kevtek Medical Products, Inc. | 1 | 1990-08-21 |
| Cymed, Inc. | 1 | 1989-05-01 |
| Zinnanti Surgical Instruments, Inc. | 1 | 1989-04-12 |
8 more applicants have FZS clearances. See the full list in Caduvo.
Most recent FZS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K932493 | Whitney Products, Inc. | SURGICAL CURETTE | 1994-01-07 | 228 |
| K902000 | Kevtek Medical Products, Inc. | KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD | 1990-08-21 | 111 |
| K892521 | Cymed, Inc. | CYMED MICROSKIN(R) DISPOSABLE IRRIGATION SLEEVE | 1989-05-01 | 20 |
| K891888 | Zinnanti Surgical Instruments, Inc. | CURRETTES - PIFFARD, WOLF, VIDAL-SCRAPER | 1989-04-12 | 19 |
| K891334 | Acuderm, Inc. | ACU-CURETTE | 1989-04-11 | 32 |
Recalls for FZS devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-12-03.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code FZS?
FZS is the FDA product code for curette, surgical, general use. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is FZS?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FZS?
Across 14 cleared submissions the average was 46 days from receipt to decision (median 26).
Which companies have the most FZS clearances?
Euro-Med Intl. (2); Whitney Products, Inc. (1); Kevtek Medical Products, Inc. (1); Cymed, Inc. (1); Zinnanti Surgical Instruments, Inc. (1).
Have FZS devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2024-12-03.
Next steps
- Run an FDA pathway report with predicate devices for product code FZS
- Run a recall and safety report across every FZS manufacturer
- Watch product code FZS 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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