Surgical Technology Laboratories, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Surgical Technology Laboratories, Inc.” (first 1980, latest 2017), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 42 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 | 1 | 45 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Surgical Technology Laboratories, Inc. took a median 45 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FWP | Prosthesis, Chin, Internal | 2 | 2 |
| FZE | Prosthesis, Nose, Internal | 2 | 2 |
| LZK | Implant, Malar | 2 | 2 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 1 | 1 |
| FYI | Appliance, Facial Fracture, External | 1 | 1 |
| FZX | Guide, Surgical, Instrument | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| GEN | Forceps, General & Plastic Surgery | 1 | 1 |
| KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | 1 | 1 |
Review panels
Most recent Surgical Technology Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170582 | Saf-T-Vac Smoke and Fluid Evacuator | GEI | 2017-04-14 | 45 |
| K021889 | SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) | KKY | 2002-10-16 | 131 |
| K983756 | SURGIFORM ANATOMICAL MALAR | LZK | 1998-11-20 | 29 |
| K983755 | NASAL DORSAL SERIES | FZE | 1998-11-20 | 29 |
| K983754 | STANDARD CHIN | FWP | 1998-11-20 | 29 |
| K964443 | SURGIFORM ANATOMICAL MALAR | LZK | 1996-12-20 | 44 |
| K840835 | STRAITH DRAIN INSERTER | FZX | 1984-04-23 | 59 |
| K831078 | STRAITH ORAL AIRWAY | CAE | 1983-06-24 | 81 |
| K801074 | STRAITH NASAL IMPLANT | FZE | 1980-06-17 | 42 |
| K801072 | STRAITH NASAL SPLINT | FYI | 1980-06-17 | 42 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Surgical Technology Laboratories, Inc..
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.
- Surgical Laser Technologies, Inc. (51 510(k)s)
- Surgical Specialties Corp (33 510(k)s)
- Surgical Technologies, Inc. (28 510(k)s)
- Surgical Navigation Technologies, Inc. (27 510(k)s)
- Surgical Instrument Service and Savings, Inc. (23 510(k)s)
- Surgical Dynamics, Inc. (12 510(k)s)
- Surgical Appliance Industries, Inc. (9 510(k)s)
- Surgical Instruments Service and Savings, Inc. (8 510(k)s)
- Surgical Theater, Inc. (8 510(k)s)
- Surgical Information Sciences, Inc. (7 510(k)s)
- Surgical Innovations Plc (7 510(k)s)
- Surgical Specialties Corp. Dba Angiotech (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Surgical Technology Laboratories, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Surgical Technology Laboratories, Inc.” (first 1980, latest 2017), across 9 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 Surgical Technology Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Surgical Technology Laboratories, Inc. is 42 days.
Which FDA product codes appear under Surgical Technology Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are FWP (Prosthesis, Chin, Internal, 2); FZE (Prosthesis, Nose, Internal, 2); LZK (Implant, Malar, 2).
Next steps
- See all 12 Surgical Technology Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FWP, Surgical Technology Laboratories, Inc.'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.