SIIS#1 TISSUE SUSPENSION SYSTEM— 510(k) K020705

Substantially Equivalent

Tag Medical Products

FDA 510(k) clearance K020705 for SIIS#1 TISSUE SUSPENSION SYSTEM, Substantially Equivalent on 2002-04-26. Applicant: Tag Medical Products.

Clearance details

Applicant: Tag Medical Products
Product code: Code OTN
Advisory panel: General, Plastic Surgery
Date received: 2002-03-04
Decision date: 2002-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kibbutz Gaaton, IL

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.