F.M. Wiest USA, Inc.: FDA clearances and approvals
F.M. Wiest USA, Inc. has 12 FDA 510(k) clearances (first 1986, latest 1994), across 8 product codes in 4 review panels. Median 510(k) review time: 145 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRX | Arthroscope | 3 | 3 |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 2 | 2 |
| HIG | Insufflator, Hysteroscopic | 2 | 2 |
| EXQ | Cystometer, Electrical Recording | 1 | 1 |
| EZN | Dilator, Catheter, Ureteral | 1 | 1 |
| HES | Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) | 1 | 1 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
| IKN | Electromyograph, Diagnostic | 1 | 1 |
Review panels
Most recent F.M. Wiest USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K921871 | HYSTEROMAT(TM) 3700 | HIG | 1994-12-15 | 969 |
| K920574 | CAMSYS 6300 | EXQ | 1993-02-17 | 376 |
| K920575 | MERKUR 4000 | FAP | 1992-07-23 | 167 |
| K915751 | URETEROMAT 4400 | EZN | 1992-04-24 | 123 |
| K911844 | HYSTEROFLATOR 1500 | HIG | 1991-11-21 | 210 |
| K912071 | SPACE(TM) 7500 | IKN | 1991-07-09 | 60 |
| K910883 | LAPAROFLATOR ELECTRONIC 3509 | HIF | 1991-03-29 | 28 |
| K875137 | LAPAROFLATOR 3000, STANDARD AND ELECTRONIC | HES | 1988-03-02 | 78 |
| K871181 | ARTHROCOMBI 5003 | HRX | 1987-09-29 | 188 |
| K871180 | ARTHRO AUTOMAT 5002 | HRX | 1987-09-29 | 188 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named F.M. Wiest USA, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does F.M. Wiest USA, Inc. have?
F.M. Wiest USA, Inc. has 12 FDA 510(k) clearances (first 1986, latest 1994), across 8 product codes in 4 review panels.
How long does FDA take to clear F.M. Wiest USA, Inc.'s 510(k)s?
The median time from FDA receipt to decision across F.M. Wiest USA, Inc.'s cleared 510(k)s is 145 days.
What devices does F.M. Wiest USA, Inc. make?
Its most frequent FDA product codes are HRX (Arthroscope, 3); FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device, 2); HIG (Insufflator, Hysteroscopic, 2).
Has F.M. Wiest USA, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching F.M. Wiest USA, Inc. Related entities may recall under other names.
Next steps
- See all 12 F.M. Wiest USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRX, F.M. Wiest USA, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.