510(k) Report

FDA applicant

American Surgical Co., Inc.

Mchenry, IL11 decisions1983–201321 recalls

FDA records 11 decisions for American Surgical Co., Inc. (Mchenry, IL) from 1983 to 2013: 11 510(k) clearances. Most are in product codes HQC (Unit, Phacofragmentation) and HQE (Instrument, Vitreous Aspiration And Cutting…). Its devices cite 3 predicates, 0 of them its own earlier devices. 21 recalls are linked to its devices.

FDA’s records also spell it “American Surgical Company, LLC”.

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

FIG. A — Illustration, ophthalmic panel, where it files most

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

FDA decisions per year

1in 2013

2012: 12013: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

21in 2016

2016: 21
2007high 21 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — American Surgical Co., 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?

  • HQCUnit, Phacofragmentation5decisions
  • HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered4decisions
  • HBANeurosurgical Paddie2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K112598American Surgical Company/ Neurosurgical Sponges (Brand)American Surgical Company, LLC · 2013
  • K121822DelicotAmerican Surgical Company, LLC · 201221 recalls
  • K834162Vit PacAmerican Surgical Co., Inc. · 1986
  • K834160Vitreonic PlusAmerican Surgical Co., Inc. · 1986
  • K841738Amer. Surgical Corp. Extra Plus PakAmerican Surgical Co., Inc. · 1984
  • K834163UltravitAmerican Surgical Co., Inc. · 1983
  • K834158Extra Sensory PlusAmerican Surgical Co., Inc. · 1983
  • K833617Extra Plus TMAmerican Surgical Co., Inc. · 1983

All 9 as American Surgical Co., Inc. →All 2 as American Surgical Company, LLC →

What has been recalled?

21 recalls linked to its devices; the latest:

  • K121822American Surgical Delicot 6 mm x 50 mm Ref Number: 63-06 Product Usage: Neurosurgical…Mar 31, 2016Class II
  • K121822American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical…Mar 31, 2016Class II
  • K121822American Surgical Delicot 13 mm x 60 mm Ref Number: 63-08 Product Usage: Neurosurgical…Mar 31, 2016Class II
  • K121822American Surgical Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgical and…Mar 31, 2016Class II
  • K121822American Surgical Delicot 5 mm x 8 mm Ref Number: 63-01 Product Usage: Neurosurgical and…Mar 31, 2016Class II
  • K121822American Surgical Delicot 10 mm x 13 mm Ref Number: 63-03 Product Usage: Neurosurgical…Mar 31, 2016Class II