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
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Applicant Contact
- Contact
- Ken Chen
- Address
- 3f., # 12, Sec. 2 Sheng Yi Rd. Zhubei City TW 30261 30261
FDA Registration Numbers
- 3002808148
- 1450662
- 3020142503
- 3030926959
- 3007593944
- 1416980
- 3011459664
- 3011277660
- 9614969
- 3004464325
- 2031917
- 1421101
- 3015453963
- 2183744
- 3013188547
- 3009039068
- 3023852420
- 3008805497
- 1216677
- 9612074
- 3030311186
- 2938071
- 2032521
- 2649614
- 3004434200
- 3030447506
- 3001556604
- 1643264
- 3011050570
- 3043225236
- 2085947
- 1423537
- 3031238646
- 8044098
- 1718850
- 3008843439
- 3010305275
- 2028523
- 3027339877
- 8010877
- 3017210488
- 8010487
- 3002807314
- 3003915875
- 3011416394
- 2916714
- 3010860245
- 2424366
- 3030733800
- 9616067
- 3007305485
- 3004530184
- 3010331645
- 3004378299
- 3009212837
- 2135348
- 3030839824
- 3014279513
- 8010591
- 3006116468
- 9613793
- 9710524
- 3015173212
- 3007421149
- 3006638824
- 3009134855
- 3043152784
- 3029950834
- 3003687489
- 3014579161
- 3014579024
- 3006897899
- 9680837
- 3014202166
- 8010418
- 1061927
- 3008040391
- 3010612620
- 3005595283
Other 510(k) Records For Product Code GCJ
| 510(k) | Device | Applicant | Decision date |
|---|
| K254228 | KARL STORZ Trocars with Valve Seals | Karl Storz SE & CO. KG | 2026-05-11 |
| K252858 | 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) | Kms Medical Technology Co., Ltd. | 2026-04-30 |
| K260197 | Shogun Axis Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) | Suzhou Shenyun Medical Equipment Co., Ltd. | 2026-04-08 |
| K260089 | TL-10 Laparoscopic Scope Cleaner | Scopix , Ltd. | 2026-04-08 |
| K252714 | C-Lant Port | Vigor Medical Technologies , Ltd. | 2026-02-27 |
| K253978 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2026-02-24 |
| K260185 | 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality | Stryker Endoscopy | 2026-02-18 |
| K260177 | Saberscope Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) | Xenocor, Inc. | 2026-02-12 |
| K251923 | Medical Shaver System (Morcellator) (YSB-IIIA) | Hangzhou Hawk Optical Electronic Instruments Co., Ltd. | 2026-01-29 |
| K252957 | Pneumo Dissector Hook | Ab Medica Sas | 2026-01-23 |
| K254014 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | Stryker Endoscopy | 2026-01-13 |
| K250927 | KARL STORZ Cholangiography Set | Karl Storz SE & CO. KG | 2025-11-22 |
| K242606 | Nuvis® Wireless HD Camera System (Nuvis-2K) | Integrated Endoscopy, Inc. | 2025-11-20 |
| K252442 | Kii Structural Balloon Access System | Applied Medical Resources Corp. | 2025-10-31 |
| K252697 | 3D Laparoscope | Guangdong Optomedic Technologies, Inc. | 2025-10-29 |