Surgitek: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Surgitek” (first 1983, latest 1995), across 18 product codes in 4 review panels. Median 510(k) review time under this name: 95 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| FAD | Stent, Ureteral | 9 | 9 |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 2 | 2 |
| FGO | Dislodger, Stone, Flexible | 2 | 2 |
| LCJ | Tissue Expander And Accessories | 2 | 2 |
| BTS | Tube, Bronchial (W/Wo Connector) | 1 | 1 |
| EYB | Catheter, Ureteral, Gastro-Urology | 1 | 1 |
| FAE | Prosthesis, Penile | 1 | 1 |
| FBO | Cystourethroscope | 1 | 1 |
| FEN | Device, Cystometric, Hydraulic | 1 | 1 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 1 | 1 |
Plus 8 more product codes.
Review panels
- Gastroenterology and Urology (23)
- General and Plastic Surgery (4)
- Anesthesiology (1)
- General Hospital (1)
Most recent Surgitek 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K946296 | QUADRA-COIL URETERAL STENT | FAD | 1995-03-06 | 69 |
| K944391 | OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM | FEN | 1995-02-07 | 151 |
| K943491 | RIGHT ANGLE UROLOGIC LASER FIBER | GEX | 1994-08-05 | 17 |
| K941952 | SURGITEK INFUSER | FAD | 1994-05-24 | 32 |
| K933261 | GRASPING FORCEPS | FGO | 1994-01-11 | 189 |
| K933260 | HELICAL STONE/FLATWIRE STONE BASKETS | FFL | 1994-01-11 | 189 |
| K930733 | URETERAL STENT | FAD | 1993-07-23 | 162 |
| K930483 | URETERAL CATHETER | EYB | 1993-07-16 | 168 |
| K926344 | HYDROPHILIC COATED GUIDEWIRE | KNY | 1993-03-05 | 78 |
| K920451 | ENDOTEK ULTRA SYSTEM | FAP | 1992-09-17 | 226 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Surgitek.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Surgitek Medical Engineering Corp. (11 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Surgitek?
FDA lists 29 510(k) clearances under the applicant name “Surgitek” (first 1983, latest 1995), across 18 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Surgitek?
The median time from FDA receipt to decision across 510(k)s cleared under the name Surgitek is 95 days.
Which FDA product codes appear under Surgitek?
The most frequent FDA product codes under this applicant name are FAD (Stent, Ureteral, 9); FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device, 2); FGO (Dislodger, Stone, Flexible, 2).
Next steps
- See all 29 Surgitek clearances with predicates and recalls
- Run predicate analysis for product code FAD, Surgitek's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.