VYDAX 525-550 & 5100 FLUOROTELOMER— 510(k) K833357

Substantially Equivalent

ETHICON, Inc.

FDA 510(k) clearance K833357 for VYDAX 525-550 & 5100 FLUOROTELOMER, Substantially Equivalent on 1983-12-12. Applicant: ETHICON, Inc..

Clearance details

Applicant: ETHICON, Inc.
Product code: Code GDT
Advisory panel: General, Plastic Surgery
Date received: 1983-09-28
Decision date: 1983-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code GDT

product code GDT

Malfunction: 752
Total: 752

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.