510(k) Report

FDA applicant

Greenwald Surgical Co., Inc.

Lake Station, IN4 decisions1978–19940 recalls

FDA records 4 decisions for Greenwald Surgical Co., Inc. (Lake Station, IN) from 1978 to 1994: 4 510(k) clearances. Most are in product codes FAS (Electrode, Electrosurgical, Active, Urological) and FHA (Clamp, Penile). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Greenwald Surgical Co., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Greenwald 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?

  • FASElectrode, Electrosurgical, Active, Urological3decisions
  • FHAClamp, Penile1decision

What has FDA decided for it lately?

  • K933174Greenwald Flexible Endoscopic ElectrodeGreenwald Surgical Co., Inc. · 1994
  • K933175Greenwald Control Tip Ureteroscopic ElectrodeGreenwald Surgical Co., Inc. · 1994
  • K933173Greenwald Control-Tip Cystoscopic ElectrodeGreenwald Surgical Co., Inc. · 1994
  • K780137Clamp, Incontinence, BaumruckerGreenwald Surgical Co., Inc. · 1978

All 4 as Greenwald Surgical Co., Inc. →