510(k) clearances

Inno-Switch™ Laparoscopic Instruments

Taiwan Surgical Corporation · General, Plastic Surgery

K252535Substantially EquivalentTraditionalGEI
Open FDA's page for this record
Third party flag
N
City
Zhubei City
Advisory committee description
General, Plastic Surgery
Address 1
3f., # 12, Sec. 12, Sheng Yi Rd., Hsinchu County
Statement or summary
Summary
Product code
GEI
Zip code
30261
Applicant
Taiwan Surgical Corporation
Decision date
2026-08-25
Decision code
SESE
Country code
TW
Device name
Inno-Switch™ Laparoscopic Instruments
Advisory committee
SU
Contact
Ken Chen
K number
K252535
Date received
2025-08-12
Review advisory committee
SU
Postal code
30261
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty description
General, Plastic Surgery
Regulation number
878.4400
Device class
2
Registration number
2184009, 1221934, 3013176080, 9680952, 3003678543, 3009380063, 3009881188, 2245590, 2431166, 3006849754, 2029275, 3004111573, 2133786, 3009882464, 3013283620, 3012447612, 3007710878, 2648623, 3004122598, 3015612252, 3010280625, 1929938, 3012497308, 3009762450, 3010288205, 3012322232, 3018242561, 1836161, 2020394, 1222993, 3006891627, 9610614, 2955842, 3011879048, 3013466775, 2032098, 3004636440, 3012790575, 9614969, 3007583504 +832 more
FEI number
1221934, 3013176080, 3003678543, 3009380063, 3009881188, 2245590, 3006849754, 3004111573, 3009882464, 3013283620, 3002808445, 3012447612, 3007710878, 2648623, 3004122598, 3015612252, 3010280625, 1929938, 3012497308, 3009762450, 3010288205, 3012322232, 3018242561, 2020394, 3006891627, 1000518731, 3011879048, 1000112877, 3013466775, 1000160458, 3002900199, 1000122656, 3003186357, 3004636440, 3012790575, 3007583504, 3040335671, 3009420598, 3010164891, 3003448211 +832 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.