InnoClip Disposable Clip Applier— 510(k) K253903

Substantially Equivalent

Taiwan Surgical Corporation

FDA 510(k) clearance K253903 for InnoClip Disposable Clip Applier, Substantially Equivalent on 2025-12-22. Applicant: Taiwan Surgical Corporation.

Clearance details

Applicant: Taiwan Surgical Corporation
Product code: Code FZP
Advisory panel: General, Plastic Surgery
Date received: 2025-12-05
Decision date: 2025-12-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Zhubei City, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code FZP

product code FZP

Death: 11
Injury: 726
Malfunction: 10,830
Other: 1
Total: 11,568

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.