510(k) K252535

Device
Inno-Switch™ Laparoscopic Instruments
Applicant
Taiwan Surgical Corporation
510(k) number
K252535
Product code
GEI
Decision
Substantially Equivalent (SESE)
Decision date
2026-08-25
Date received
2025-08-12
Regulation
878.4400
Classification name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Ken Chen
Address
3f., # 12, Sec. 12, Sheng Yi Rd., Hsinchu County Zhubei City TW 30261 30261

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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