MANI NEEDLE & SUTURE PACK (SILK)— 510(k) K053638

Substantially Equivalent

Mani, Inc.

FDA 510(k) clearance K053638 for MANI NEEDLE & SUTURE PACK (SILK), Substantially Equivalent on 2006-05-19. Applicant: Mani, Inc..

Clearance details

Applicant: Mani, Inc.
Product code: Code GAP
Advisory panel: General, Plastic Surgery
Date received: 2005-12-29
Decision date: 2006-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code GAP

product code GAP

Death: 3
Injury: 491
Malfunction: 2,253
Total: 2,747

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.