SUTTER PHALANGEAL CAP— 510(k) K875249

Substantially Equivalent

Sutter Biomedical, Inc.

FDA 510(k) clearance K875249 for SUTTER PHALANGEAL CAP, Substantially Equivalent on 1988-02-03. Applicant: Sutter Biomedical, Inc..

Clearance details

Applicant: Sutter Biomedical, Inc.
Product code: Code KWD
Advisory panel: Orthopedic
Date received: 1987-12-22
Decision date: 1988-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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Adverse events under product code KWD

product code KWD

Injury: 164
Total: 164

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.