510(k) Report

FDA applicant

Surgical Technology Laboratories, Inc.

Mchenry, IL12 decisions1980–20170 recalls

FDA records 12 decisions for Surgical Technology Laboratories, Inc. (Mchenry, IL) from 1980 to 2017: 12 510(k) clearances. Most are in product codes FZE (Prosthesis, Nose, Internal) and LZK (Implant, Malar). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Surgical Technology Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Surgical Technology Laboratories, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FZEProsthesis, Nose, Internal2decisions
  • LZKImplant, Malar2decisions
  • FWPProsthesis, Chin, Internal2decisions
  • FZXGuide, Surgical, Instrument1decision
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision
  • CAEAirway, Oropharyngeal, Anesthesiology1decision

Also: FYI (1), KKY (1), GEN (1).

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K021889Surgiform Augmentation Material (S.F.a.M.)Surgical Technology Laboratories, Inc. · 20022cite it
  • K983756Surgiform Anatomical MalarSurgical Technology Laboratories, Inc. · 19981cites it
  • K983755Nasal Dorsal SeriesSurgical Technology Laboratories, Inc. · 19981cites it
  • K983754Standard ChinSurgical Technology Laboratories, Inc. · 19981cites it

What has FDA decided for it lately?

  • K170582Saf-T-Vac Smoke and Fluid EvacuatorSurgical Technology Laboratories, Inc. · 2017
  • K021889Surgiform Augmentation Material (S.F.a.M.)Surgical Technology Laboratories, Inc. · 2002
  • K983756Surgiform Anatomical MalarSurgical Technology Laboratories, Inc. · 1998
  • K983755Nasal Dorsal SeriesSurgical Technology Laboratories, Inc. · 1998
  • K983754Standard ChinSurgical Technology Laboratories, Inc. · 1998
  • K964443Surgiform Anatomical MalarSurgical Technology Laboratories, Inc. · 1996
  • K840835Straith Drain InserterSurgical Technology Laboratories, Inc. · 1984
  • K831078Straith Oral AirwaySurgical Technology Laboratories, Inc. · 1983

All 12 as Surgical Technology Laboratories, Inc. →