Data / Medical devices / United States / Surgical Technology Laboratories Inc.
Surgical Technology Laboratories Inc.: FDA-registered device maker in Lugoff, SC, United States, 6 510(k) clearances
Surgical Technology Laboratories Inc. is registered with the FDA (registration 1825527) in Lugoff, SC, United States. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 14, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1825527
- Address
- 1566 Whiting Way, Lugoff, SC, United States, 29078
- Owner or operator
- SURGICAL TECHNOLOGY LABORATORIES INC. (1825527)
- Roles
- Manufacturer
- First device listed
- May 22, 1979
- Registered through
- 2026
- Brand names listed
- Odifile Nasal Implant, PureForm, SFAM, SFAM 3-D, Saf-T-Vac Smoke and Fluid Evacuator, ScarX, Straight Chin, Straith Nasal Implant and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Implant, Malar | LZK | 2 | Manufacturer | accessdata.fda.gov |
| Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | KKY | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Chin, Internal | FWP | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Nose, Internal | FZE | 2 | Manufacturer | accessdata.fda.gov |
| Silicone Hydrogel For Scar Management | PFP | 1 | Manufacturer | accessdata.fda.gov |
| Splint, Nasal | EPP | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 14, 2017 | K170582 | Saf-T-Vac Smoke and Fluid Evacuator | GEI | Substantially Equivalent | Surgical Technology Laboratories, Inc. | accessdata.fda.gov |
| April 22, 2009 | K091011 | PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) | FWP | Substantially Equivalent | Surgical Technology Laboratories, Inc ("Stl") | accessdata.fda.gov |
| October 16, 2002 | K021889 | SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) | KKY | Substantially Equivalent | Surgical Technology Laboratories, Inc. | accessdata.fda.gov |
| November 20, 1998 | K983756 | SURGIFORM ANATOMICAL MALAR | LZK | Substantially Equivalent | Surgical Technology Laboratories, Inc. | accessdata.fda.gov |
| November 20, 1998 | K983755 | NASAL DORSAL SERIES | FZE | Substantially Equivalent | Surgical Technology Laboratories, Inc. | accessdata.fda.gov |
| November 20, 1998 | K983754 | STANDARD CHIN | FWP | Substantially Equivalent | Surgical Technology Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Splint, Nasal
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Silicone Hydrogel For Scar Management
- All makers of Prosthesis, Nose, Internal
- All makers of Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
- All makers of Implant, Malar
Updated April 14, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.