Inno-Switch Laparoscopic Instruments— 510(k) K252535

Name: FDA 510(k) clearance K252535
Creator: U.S. Food and Drug Administration
Published: 2026-08-25

Substantially Equivalent

Taiwan Surgical Corporation

FDA 510(k) clearance K252535 for Inno-Switch Laparoscopic Instruments, Substantially Equivalent on 2026-08-25. Applicant: Taiwan Surgical Corporation. Device class: 2.

Clearance details

Applicant: Taiwan Surgical Corporation
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2025-08-12
Decision date: 2026-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhubei City, TW

Download summary PDF View on FDA.gov ↗

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More clearances from Taiwan Surgical Corporation

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K254231 — Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips2026-07-20
K252532 — Inno-Port Disposable Bladed Trocar2026-06-02
K253781 — InnoClip Clip Applier2025-12-22
K253903 — InnoClip Disposable Clip Applier2025-12-22
K223593 — Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar2023-03-22

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.