BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE— 510(k) K992088

Substantially Equivalent

Genzyme Surgical Product (Genzyme Biosurgery)

FDA 510(k) clearance K992088 for BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE, Substantially Equivalent on 1999-09-03. Applicant: Genzyme Surgical Product (Genzyme Biosurgery).

Clearance details

Applicant: Genzyme Surgical Product (Genzyme Biosurgery)
Product code: Code GAM
Advisory panel: General, Plastic Surgery
Date received: 1999-06-21
Decision date: 1999-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fall River, MA, US

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Adverse events under product code GAM

product code GAM

Death: 45
Injury: 5,711
Malfunction: 30,744
Other: 4
Total: 36,504

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.