ORTHOPEDIC PACKS— 510(k) K951231

Name: FDA 510(k) clearance K951231
Creator: U.S. Food and Drug Administration
Published: 1995-12-01

Substantially Equivalent

Sterile Concepts, Inc.

FDA 510(k) clearance K951231 for ORTHOPEDIC PACKS, Substantially Equivalent on 1995-12-01. Applicant: Sterile Concepts, Inc.. Device class: 2.

Clearance details

Applicant: Sterile Concepts, Inc.
Product code: Code GAN
Device class: Class 2
Regulation: 21 CFR 878.4830
Advisory panel: General, Plastic Surgery
Date received: 1995-03-20
Decision date: 1995-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, VA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GAN

product code GAN

Injury: 599
Malfunction: 1,658
Total: 2,257

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.