SHOVEL RETRACTOR— 510(k) K822109

Name: FDA 510(k) clearance K822109
Creator: U.S. Food and Drug Administration
Published: 1982-07-30

Substantially Equivalent

Bio-Blitz, Inc.

FDA 510(k) clearance K822109 for SHOVEL RETRACTOR, Substantially Equivalent on 1982-07-30. Applicant: Bio-Blitz, Inc.. Device class: 1.

Clearance details

Applicant: Bio-Blitz, Inc.
Product code: Code NBH
Device class: Class 1
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 1982-07-19
Decision date: 1982-07-30
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 NBH

product code NBH

Injury: 516
Malfunction: 2,389
Total: 2,905

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.