510(k) Report

FDA applicant

Innovative Surgical, Inc.

West Palm Beach, FL7 decisions1993–19950 recalls

FDA records 7 decisions for Innovative Surgical, Inc. (West Palm Beach, FL) from 1993 to 1995: 7 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and GEI (Electrosurgical, Cutting & Coagulation &…). 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 Innovative Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Innovative Surgical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Innovative Surgical, 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?

  • GCJLaparoscope, General & Plastic Surgery5decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision
  • GFIOsteotome, Manual1decision

What has FDA decided for it lately?

  • K945394Innovative Surgical (R) Mangum Knot PusherInnovative Surgical, Inc. · 1995
  • K932696Isi (R) Curved, Tapered Dissecting ForcepsInnovative Surgical, Inc. · 1994
  • K932695Isi (R) Porpoise Nose Dissecting ForcepsInnovative Surgical, Inc. · 1994
  • K934075Isi Metzenbaum ScissorsInnovative Surgical, Inc. · 1993
  • K932697Isi (R) Hook Suture Scissors, MonopolarInnovative Surgical, Inc. · 1993
  • K932698Isi (R) Hook Sutures ScissorsInnovative Surgical, Inc. · 1993
  • K932534Isi Fenestrated Dissecting and Grasping ForcepsInnovative Surgical, Inc. · 1993

All 7 as Innovative Surgical, Inc. →