510(k) Report

FDA applicant

Hemostatic Surgery Corp.

San Francisco, CA1 decision1990–19902 recalls

FDA records 1 decision for Hemostatic Surgery Corp. (San Francisco, CA) in 1990: 1 510(k) clearance. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). 2 recalls are 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 Hemostatic Surgery Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hemostatic Surgery Corp. since 2007.

Recalls per year

2in 2010

2010: 2
2007high 2 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Hemostatic Surgery Corp. 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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K902307Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 19902cite it

What has FDA decided for it lately?

  • K902307Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 19902 recalls

The one decision as Hemostatic Surgery Corp. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K033089HEMOSTATIX HANDLE, FOR USE WITH MODELS 150 AND 600D HEMOSTATIX CONTROLLERS, REF…Jul 27, 2010
  • K033089MODEL P8400 HANDLE WITH INTEGRATED CABLE, FOR USE WITH MODEL P8400 CONTROLLER, REF…Jul 27, 2010