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FDA 510(k)

Inno-Switch™ Laparoscopic Instruments

K-Number: K252535 · 2026-08-25

ApplicantTaiwan Surgical Corporation
Decision Date2026-08-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Inno-Switch™ Laparoscopic Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Surgical Corporation. It received FDA 510(k) clearance on 2026-08-25 under 510(k) number K252535. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Inno-Switch™ Laparoscopic Instruments?

Inno-Switch™ Laparoscopic Instruments is a medical device that received FDA 510(k) clearance on 2026-08-25. The listed applicant is Taiwan Surgical Corporation. The 510(k) number is K252535.

When did Inno-Switch™ Laparoscopic Instruments receive FDA 510(k) clearance?

Inno-Switch™ Laparoscopic Instruments received FDA 510(k) clearance on 2026-08-25, under 510(k) number K252535.

Who is the listed applicant for Inno-Switch™ Laparoscopic Instruments?

The FDA 510(k) record lists Taiwan Surgical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Inno-Switch™ Laparoscopic Instruments?

The FDA product code for Inno-Switch™ Laparoscopic Instruments is GEI.

Other records listing Taiwan Surgical Corporation as applicant

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Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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