Surgical Technology Laboratories Inc.
Lugoff, SC, US
SURGICAL TECHNOLOGY LABORATORIES INC. appears in FDA device records in Lugoff, SC. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Surgical Technology Laboratories Inc. between 1980 and 2017. The busiest year on record is 1980, with 4. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 4 |
| 1983 | 1 |
| 1984 | 1 |
| 1996 | 1 |
| 1998 | 3 |
| 2002 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K170582 | Saf-T-Vac Smoke and Fluid Evacuator | GEI | Substantially Equivalent | |
| K021889 | SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) | KKY | Substantially Equivalent | |
| K983756 | SURGIFORM ANATOMICAL MALAR | LZK | Substantially Equivalent | |
| K983755 | NASAL DORSAL SERIES | FZE | Substantially Equivalent | |
| K983754 | STANDARD CHIN | FWP | Substantially Equivalent | |
| K964443 | SURGIFORM ANATOMICAL MALAR | LZK | Substantially Equivalent | |
| K840835 | STRAITH DRAIN INSERTER | FZX | Substantially Equivalent | |
| K831078 | STRAITH ORAL AIRWAY | CAE | Substantially Equivalent | |
| K801074 | STRAITH NASAL IMPLANT | FZE | Substantially Equivalent | |
| K801072 | STRAITH NASAL SPLINT | FYI | Substantially Equivalent | |
| K801075 | STRAITH CHISEL FORCEPS | GEN | Substantially Equivalent | |
| K801073 | STRAITH CHIN IMPLANTS | FWP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1825527 | 1825527 | SURGICAL TECHNOLOGY LABORATORIES INC. | 1566 Whiting Way, Lugoff, SC 29078 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CAEAirway, Oropharyngeal, Anesthesiology
- FYIAppliance, Facial Fracture, External
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GENForceps, General & Plastic Surgery
- FZXGuide, Surgical, Instrument
- LZKImplant, Malar
- KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
- FWPProsthesis, Chin, Internal
- FZEProsthesis, Nose, Internal
- PFPSilicone Hydrogel For Scar Management
- EPPSplint, Nasal
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain