Surgical Technologies, Inc.: FDA clearances and approvals
Surgical Technologies, Inc. has 28 FDA 510(k) clearances (first 1991, latest 1995), across 17 product codes in 9 review panels. Median 510(k) review time: 102 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 7 | 7 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 4 | 4 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 2 | 2 |
| EQH | Source, Carrier, Fiberoptic Light | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| FBO | Cystourethroscope | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 | 1 |
| GBX | Catheter, Irrigation | 1 | 1 |
| GCM | Endoscope, Rigid | 1 | 1 |
Plus 7 more product codes.
Review panels
- General and Plastic Surgery (9)
- Ophthalmic (6)
- Ear, Nose and Throat (4)
- Gastroenterology and Urology (3)
- Cardiovascular (2)
- General Hospital (1)
- Obstetrics and Gynecology (1)
- Orthopedic (1)
- Radiology (1)
Most recent Surgical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K941992 | CYSTOSCOPE | FBO | 1995-11-30 | 584 |
| K942029 | ARTHROSCOPE | HRX | 1995-11-08 | 561 |
| K946136 | INFINITECH LIGHTED INFUSION CANNULA | MPA | 1995-10-02 | 290 |
| K952566 | OSCILFLATOR | MAV | 1995-08-31 | 90 |
| K951918 | SURGICAL TECHNOLOGIES, INC. SYRINGE | FMF | 1995-07-20 | 87 |
| K950683 | ARTHROGRAM TRAY | JAA | 1995-05-06 | 81 |
| K946135 | INFINITECH ASPIRATING LASER PROBE | HQE | 1995-04-18 | 123 |
| K946181 | INFINITECH SOFT TIP FLUTE NEEDLE | HQE | 1995-03-14 | 84 |
| K942030 | BIOPSY SCISSORS | OCZ | 1994-06-27 | 62 |
| K942482 | PRESSURE MONITORING EXTENSION | DQO | 1994-06-14 | 20 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Surgical Technologies, 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 Surgical Technologies, Inc. have?
Surgical Technologies, Inc. has 28 FDA 510(k) clearances (first 1991, latest 1995), across 17 product codes in 9 review panels.
How long does FDA take to clear Surgical Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Surgical Technologies, Inc.'s cleared 510(k)s is 102 days.
What devices does Surgical Technologies, Inc. make?
Its most frequent FDA product codes are GCJ (Laparoscope, General & Plastic Surgery, 7); HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered, 4); EOQ (Bronchoscope (Flexible Or Rigid), 2).
Has Surgical Technologies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Surgical Technologies, Inc. Related entities may recall under other names.
Next steps
- See all 28 Surgical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Surgical Technologies, 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.