FDA product code FZT: Cutter, Surgical
FZT is the FDA product code for cutter, surgical. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 52 510(k) submissions under FZT, from 19 different applicants. The average 510(k) review took 23 days (median 20). FDA has posted 6 recalls for FZT devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Cutter, Surgical |
| 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 FZT clearance
Top FZT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Conphar, Inc. | 21 | 1982-05-27 |
| Edward Weck, Inc. | 5 | 1979-10-17 |
| Dentronix, Inc. | 5 | 1977-03-09 |
| Sea-Pac Trading Corp. | 4 | 1977-04-15 |
| J. Sklar Mfg. Co., Inc. | 2 | 1982-09-14 |
14 more applicants have FZT clearances. See the full list in Caduvo.
Most recent FZT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K112400 | Nuscience Consulting and Management Group, LLC | SMARTSHEARS | 2011-09-12 | 24 |
| K890818 | United States Surgical, A Division of Tyco Healthc | AUTO SUTURE DISPOSABLE SURGICAL TROCAR* | 1989-05-04 | 76 |
| K872990 | Micrins Surgical, Inc. | MICRINS SURGICAL SCISSOR | 1987-08-17 | 17 |
| K841741 | Paris Products, Inc. | SINGLE HAIR TRANSPLANT GRAFT | 1984-07-23 | 91 |
| K841247 | Surgical Products Corp. | SPC DISPOSABLE CUTTER | 1984-05-02 | 42 |
Recalls for FZT devices
6 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 FZT?
FZT is the FDA product code for cutter, surgical. 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 FZT?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FZT?
Across 52 cleared submissions the average was 23 days from receipt to decision (median 20).
Which companies have the most FZT clearances?
Conphar, Inc. (21); Edward Weck, Inc. (5); Dentronix, Inc. (5); Sea-Pac Trading Corp. (4); J. Sklar Mfg. Co., Inc. (2).
Have FZT devices been recalled?
Yes: 6 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 FZT
- Run a recall and safety report across every FZT manufacturer
- Watch product code FZT 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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