510(k) K960327— NYLON NOABSORBABLE SURGICAL SUTURES USP

Substantially Equivalent for Some Indications

R. K. Medical L. L. C.

Clearance details

Applicant: R. K. Medical L. L. C.
Product code: Code GAR
Advisory panel: General, Plastic Surgery
Date received: 1996-01-24
Decision date: 1996-03-04
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Mahwah, NJ, US

Adverse events under product code GAR

product code GAR

Injury: 422
Malfunction: 3,386
Other: 4
Total: 3,812

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.