510(k) K240635
- Device
- ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT Specimen Retrieval Bag, 15mm
- Applicant
- Ximedica
- 510(k) number
- K240635
- Product code
- GCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-04-01
- Date received
- 2024-03-06
- Regulation
- 876.1500
- Classification name
- Laparoscope, General & Plastic Surgery
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Corie Vazquez
- Address
- 55 Dupont Dr. Providence RI US 02907 02907
FDA Registration Numbers#
- 3014579024
- 3011459664
- 3005441393
- 3001675293
- 3010220244
- 3011373951
- 3004111573
- 1218882
- 1526012
- 2431166
- 9614209
- 3013002341
- 1056128
- 3005699784
- 3010612620
- 3035708926
- 3014296178
- 3013184361
- 3022626486
- 2916714
- 3017262662
- 8022210
- 3017210488
- 1221072
- 3009881188
- 3014579161
- 2518417
- 3017196117
- 3010041511
- 3013176080
- 3009217531
- 3015542154
- 3006498370
- 8043746
- 3027339877
- 2529647
- 9681834
- 1319639
- 2246552
- 9611594
- 3021336392
- 1221826
- 3007137643
- 3021744308
- 3030153385
- 3008837339
- 2647580
- 9613793
- 3014273609
- 1720747
- 1718850
- 3008729892
- 3011052945
- 3016112537
- 1531174
- 9681191
- 3011416394
- 1219930
- 2030624
- 1055236
- 8010168
- 1928237
- 1320468
- 3045857302
- 3007516837
- 1828132
- 3009057691
- 3011936016
- 3009756153
- 2320767
- 1423537
- 3021744379
- 9680837
- 9612501
- 3007703432
- 3008911114
- 3008383115
- 1820334
- 9614434
Source Documents#
Other 510(k) Records For Product Code GCJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260710 | FloShield 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. | 2026-06-11 |
| K260414 | “Tech-Image” Video Endoscope System | Tech-Image CO., LTD. | 2026-06-10 |
| K253994 | TroKit Laparoscope Lens Wiper | TroCare, LLC | 2026-06-04 |
| K252532 | Inno-Port Disposable Bladed Trocar | Taiwan Surgical Corporation | 2026-06-02 |
| K260318 | 4K NIR/ICG Imaging System | Zhejiang Healnoc Technology Co., Ltd. | 2026-05-26 |
| K260183 | MediBot Needle Driver Uno | Parallel Robotics, LLC | 2026-05-24 |
| K252985 | Laport | Sejong Medical Co., Ltd. | 2026-05-19 |
| 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 |