SPECTRA MEDICAL SAFETY SCAPEL— 510(k) K091462

Name: FDA 510(k) clearance K091462
Creator: U.S. Food and Drug Administration
Published: 2009-12-15

Substantially Equivalent

Spectra, Inc.

FDA 510(k) clearance K091462 for SPECTRA MEDICAL SAFETY SCAPEL, Substantially Equivalent on 2009-12-15. Applicant: Spectra, Inc.. Device class: 1.

Clearance details

Applicant: Spectra, Inc.
Product code: Code GDZ
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 2009-05-18
Decision date: 2009-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GDZ

product code GDZ

Other: 1
Total: 1

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.