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Parker Quality & Compliance

PQC Reg Watch

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510(k) clearance

Inno-Switch™ Laparoscopic Instruments

FDA 510(k) source

510(k) number
K252535
Applicant
Taiwan Surgical Corporation
Decision date
Aug 25, 2026
Date received
Aug 12, 2025
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
GEI
Device type
Electrosurgical, Cutting & Coagulation & Accessories
Device class
Class II
Regulation
21 CFR 878.4400
Advisory committee
General, Plastic Surgery
Statement or summary
Summary
Third party
N
Location
Zhubei City, TW