Surgitek Medical Engineering Corp.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Surgitek Medical Engineering Corp.” (first 1990, latest 1992), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 77 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 2 | 2 |
| FAD | Stent, Ureteral | 1 | 1 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
| FCL | Forceps, Biopsy, Non-Electric | 1 | 1 |
| FDX | Endoscopic Cytology Brush | 1 | 1 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 1 | 1 |
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 1 | 1 |
| ODD | Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula | 1 | 1 |
Review panels
Most recent Surgitek Medical Engineering Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K914504 | CYTOLOGY BRUSH | FDX | 1992-02-18 | 132 |
| K914495 | E.R.C.P. CATHETER | FGE | 1992-01-30 | 114 |
| K914497 | BIOPSY FORCEPS | FCL | 1992-01-03 | 87 |
| K914505 | STONE BASKET | FFL | 1991-12-09 | 61 |
| K914503 | GRASPING FORCEPS | OCZ | 1991-12-05 | 57 |
| K914496 | SCLEROTHERAPY NEEDLE | FBK | 1991-12-05 | 58 |
| K913928 | SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT | FAD | 1991-11-19 | 77 |
| K913294 | SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT | GCA | 1991-10-04 | 72 |
| K910769 | SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM | ODD | 1991-06-25 | 123 |
| K910768 | SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE | FGE | 1991-03-19 | 25 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Surgitek Medical Engineering Corp..
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 (29 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Surgitek Medical Engineering Corp.?
FDA lists 11 510(k) clearances under the applicant name “Surgitek Medical Engineering Corp.” (first 1990, latest 1992), across 10 product codes in 2 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 Medical Engineering Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Surgitek Medical Engineering Corp. is 77 days.
Which FDA product codes appear under Surgitek Medical Engineering Corp.?
The most frequent FDA product codes under this applicant name are FGE (Stents, Drains And Dilators For The Biliary Ducts, 2); FAD (Stent, Ureteral, 1); FBK (Endoscopic Injection Needle, Gastroenterology-Urology, 1).
Next steps
- See all 11 Surgitek Medical Engineering Corp. clearances with predicates and recalls
- Run predicate analysis for product code FGE, Surgitek Medical Engineering Corp.'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.