GAMMA RADIATION STERILIZATION PRECEDURE— 510(k) K781668

Name: FDA 510(k) clearance K781668
Creator: U.S. Food and Drug Administration
Published: 1978-11-03

Substantially Equivalent

Cutter Laboratories, Inc.

FDA 510(k) clearance K781668 for GAMMA RADIATION STERILIZATION PRECEDURE, Substantially Equivalent on 1978-11-03. Applicant: Cutter Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Cutter Laboratories, Inc.
Product code: Code KYJ
Device class: Class 2
Regulation: 21 CFR 888.3230
Advisory panel: Orthopedic
Date received: 1978-09-28
Decision date: 1978-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KYJ

product code KYJ

Injury: 210
Total: 210

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.