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510(k) K223593

Device
Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar
Applicant
Taiwan Surgical Corporation
510(k) number
K223593
Product code
GCJ
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-22
Date received
2022-12-01
Regulation
876.1500
Classification name
Laparoscope, General & Plastic Surgery
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ken Chen
Address
3f., # 12, Sec. 2 Sheng Yi Rd. Zhubei City TW 30261 30261

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GCJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253994TroKit Laparoscope Lens WiperTroCare, LLC2026-06-04
K252532Inno-Port Disposable Bladed TrocarTaiwan Surgical Corporation2026-06-02
K2603184K NIR/ICG Imaging SystemZhejiang Healnoc Technology Co., Ltd.2026-05-26
K260183MediBot Needle Driver UnoParallel Robotics, LLC2026-05-24
K252985LaportSejong Medical Co., Ltd.2026-05-19
K254228KARL STORZ Trocars with Valve SealsKarl Storz SE & CO. KG2026-05-11
K2528584K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)Kms Medical Technology Co., Ltd.2026-04-30
K260197Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)Suzhou Shenyun Medical Equipment Co., Ltd.2026-04-08
K260089TL-10 Laparoscopic Scope CleanerScopix , Ltd.2026-04-08
K252714C-Lant PortVigor Medical Technologies , Ltd.2026-02-27
K253978Universal Seal (5-12 mm)Intuitive Surgical, Inc.2026-02-24
K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy2026-02-18
K260177Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)Xenocor, Inc.2026-02-12
K251923Medical Shaver System (Morcellator) (YSB-IIIA)Hangzhou Hawk Optical Electronic Instruments Co., Ltd.2026-01-29
K252957Pneumo Dissector HookAb Medica Sas2026-01-23