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FDA 510(k)

Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar

K-Number: K223593 · 2023-03-22

ApplicantTaiwan Surgical Corporation
Decision Date2023-03-22
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar 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 2023-03-22 under 510(k) number K223593. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar?

Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar is a medical device that received FDA 510(k) clearance on 2023-03-22. The listed applicant is Taiwan Surgical Corporation. The 510(k) number is K223593.

When did Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar receive FDA 510(k) clearance?

Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar received FDA 510(k) clearance on 2023-03-22, under 510(k) number K223593.

Who is the listed applicant for Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar?

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-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar?

The FDA product code for Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar is GCJ.

Other records listing Taiwan Surgical Corporation as applicant

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.

K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsK252532Inno-Port Disposable Bladed TrocarK253903InnoClip Disposable Clip ApplierK253781InnoClip Clip ApplierK202994InnoClip Disposable Clip Applier, InnoClip Clip Applier

Related Devices (Code: GCJ)

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.

K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.IncK261249Universal Seal (5-12 mm)Intuitive Surgical, Inc.K260710FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)FloShield, Inc.K260414“Tech-Image” Video Endoscope SystemTech-Image CO., LTD.

Official Source

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

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