Inno-Switch Laparoscopic Instruments— 510(k) K252535
Substantially EquivalentTaiwan 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.
Summary
Taiwan Surgical Corporation's Inno-Switch Laparoscopic Instruments are filed under product code GEI, electrosurgical cutting and coagulation devices and accessories. The record doesn't list individual instruments or model numbers.
Class II, 21 CFR 878.4400. General and Plastic Surgery is both the classification panel and the review panel. The submission was a Traditional 510(k).
The company filed from Zhubei City, Taiwan. The substantially equivalent decision came 378 calendar days after receipt (August 12, 2025 to August 25, 2026).
Clearance details
- Applicant
- Taiwan Surgical Corporation
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zhubei City, TW
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More clearances from Taiwan Surgical Corporation
view allAdverse 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, 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.