AMER. V. MUELLER SURGICALSTAPLES-CARTR— 510(k) K833704

Name: FDA 510(k) clearance K833704
Creator: U.S. Food and Drug Administration
Published: 1983-12-29

Substantially Equivalent

American Heyer Schulte

FDA 510(k) clearance K833704 for AMER. V. MUELLER SURGICALSTAPLES-CARTR, Substantially Equivalent on 1983-12-29. Applicant: American Heyer Schulte. Device class: 2.

Clearance details

Applicant: American Heyer Schulte
Product code: Code GDW
Device class: Class 2
Regulation: 21 CFR 878.4750
Advisory panel: General, Plastic Surgery
Date received: 1983-10-18
Decision date: 1983-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GDW

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K260196 — ETHICON Circular Stapler (CDH21mm) +7 more2026-05-11
K253657 — Tri-staple 2.0 Reloads +3 more2026-04-10
K252739 — ETHICON 4000 45mm Compact Stapler (EC3DT45C) +6 more2025-12-17
K250835 — ETHICON 4000 60mm Compact Stapler (EC3D60C) +6 more2025-05-14
K243276 — ECHELON LINEAR Stapler 30mm Stapler (GTX30) +8 more2025-02-25

More clearances from American Heyer Schulte

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K840172 — VENTRAL WALL DEFECT REDUCT SILO1984-06-27
K834593 — ONE-PIECE SHUNT1984-04-03
K833502 — RADOVAN SUBCUTANEOUS TISSUE EXPANDER1984-02-03
K833698 — AMER. V. MUELLER SURG. STAPLES ILA1984-01-25
K832738 — HEYER-SCHULTE AFTERLOADING CATHETER1983-09-29

Adverse events under product code GDW

product code GDW

Death: 450
Injury: 12,684
Malfunction: 68,730
Other: 6
Total: 81,870

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.