SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS— 510(k) K871478

Name: FDA 510(k) clearance K871478
Creator: U.S. Food and Drug Administration
Published: 1987-05-07

Substantially Equivalent

Procedure Pak, Inc.

FDA 510(k) clearance K871478 for SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS, Substantially Equivalent on 1987-05-07. Applicant: Procedure Pak, Inc.. Device class: 1.

Clearance details

Applicant: Procedure Pak, Inc.
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1987-04-14
Decision date: 1987-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Asheville, NC, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FSM

product code FSM

Malfunction: 1,289
Total: 1,289

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.