Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips— 510(k) K254231
Substantially EquivalentTaiwan Surgical Corporation
FDA 510(k) clearance K254231 for Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips, Substantially Equivalent on 2026-07-20. Applicant: Taiwan Surgical Corporation. Device class: 2.
Summary
Taiwan Surgical's clearance covers Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips, filed under FZP, implantable clips. The record doesn't give clip sizes or materials.
Class II, 21 CFR 878.4300. General and Plastic Surgery is both the classification panel and the review panel. It was a Traditional 510(k).
Taiwan Surgical filed from Zhubei City, Taiwan. Review took 203 calendar days (December 29, 2025 to July 20, 2026).
Clearance details
- Applicant
- Taiwan Surgical Corporation
- Product code
- Product code FZP
- Device class
- Class 2
- Regulation
- 21 CFR 878.4300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zhubei City, TW
Recent devices under product code FZP
view allMore clearances from Taiwan Surgical Corporation
view all- K252535 — Inno-Switch Laparoscopic Instruments
- K252532 — Inno-Port Disposable Bladed Trocar
- K223593 — Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar
- K202994 — InnoClip Disposable Clip Applier, InnoClip Clip Applier
- K150259 — CLIP PLUS Disposable Clip Applier,ML; CLIP PLUS Disposable Clip Applier,L
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, through . 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.