ISLAND BIOSURGICAL BOLSTER— 510(k) K960101

Substantially Equivalent

Island Biosurgical, Inc.

FDA 510(k) clearance K960101 for ISLAND BIOSURGICAL BOLSTER, Substantially Equivalent on 1996-12-16. Applicant: Island Biosurgical, Inc..

Clearance details

Applicant: Island Biosurgical, Inc.
Product code: Code OTN
Advisory panel: General, Plastic Surgery
Date received: 1996-01-11
Decision date: 1996-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mercer Island, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OTN

product code OTN

Injury: 6,630
Total: 6,630

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.