Medical Engineering Corp.: FDA clearances and approvals
Medical Engineering Corp. has 28 FDA 510(k) clearances (first 1977, latest 1993), across 15 product codes in 5 review panels. Median 510(k) review time: 60 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 |
|---|---|---|---|
| FAD | Stent, Ureteral | 5 | 5 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 3 | 3 |
| LJE | Catheter, Nephrostomy | 3 | 3 |
| DWS | Instruments, Surgical, Cardiovascular | 2 | 2 |
| FAE | Prosthesis, Penile | 2 | 2 |
| FRL | Fiber, Medical, Absorbent | 2 | 2 |
| LCJ | Tissue Expander And Accessories | 2 | 2 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 | 1 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 1 | 1 |
Plus 5 more product codes.
Review panels
- Gastroenterology and Urology (16)
- General and Plastic Surgery (4)
- Anesthesiology (2)
- Cardiovascular (2)
- General Hospital (2)
Most recent Medical Engineering Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934141 | STAND ALONE CYSTOMETROGRAM | FEN | 1993-11-18 | 85 |
| K905289 | SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT | FAD | 1991-03-13 | 107 |
| K903448 | SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER | LCJ | 1991-01-14 | 167 |
| K902773 | SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET | FGB | 1990-07-16 | 21 |
| K884746 | SURGITEK FLAT T-SPAN | LCJ | 1989-08-10 | 269 |
| K883274 | SURGITEK (R) UROFLOW SYSTEM | FFG | 1989-02-08 | 189 |
| K881736 | SURGITEK CO2 DELIVERY SYSTEM | FAP | 1988-08-11 | 111 |
| K880802 | SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11 | FGB | 1988-05-26 | 87 |
| K880801 | SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9 | FGB | 1988-05-26 | 87 |
| K842748 | SURGITEK RECONSTRUC-NIPPLE PROSTHESIS | — | 1984-09-26 | 75 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medical Engineering Corp..
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 Medical Engineering Corp. have?
Medical Engineering Corp. has 28 FDA 510(k) clearances (first 1977, latest 1993), across 15 product codes in 5 review panels.
How long does FDA take to clear Medical Engineering Corp.'s 510(k)s?
The median time from FDA receipt to decision across Medical Engineering Corp.'s cleared 510(k)s is 60 days.
What devices does Medical Engineering Corp. make?
Its most frequent FDA product codes are FAD (Stent, Ureteral, 5); FGB (Ureteroscope And Accessories, Flexible/Rigid, 3); LJE (Catheter, Nephrostomy, 3).
Has Medical Engineering Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Medical Engineering Corp. Related entities may recall under other names.
Next steps
- See all 28 Medical Engineering Corp. clearances with predicates and recalls
- Run predicate analysis for product code FAD, Medical Engineering Corp.'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.