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#
- 1423537
- 9681147
- 3003898360
- 3030311186
- 3011373951
- 1519132
- 3010400865
- 3042225166
- 3013700547
- 3005809810
- 3008383115
- 3013002341
- 3011416394
- 2320767
- 3016248634
- 3010400367
- 3011986317
- 1047843
- 2936485
- 2032521
- 1421101
- 3015895045
- 9681191
- 3003713161
- 3006161756
- 3008868758
- 3001675293
- 1054241
- 2245304
- 1928237
- 1000181154
- 3016667340
- 8010273
- 3009134855
- 1032347
- 1219930
- 3008729892
- 3010564249
- 9611665
- 1220477
- 9614969
- 3024137003
- 9611274
- 3010055973
- 9614434
- 3007766601
- 3010273872
- 3010160527
- 3029950834
- 3017102971
- 3003903031
- 3001722928
- 3008386005
- 2085947
- 3004091527
- 3012453745
- 2126670
- 2530138
- 3027500817
- 3011230048
- 3018126215
- 1820334
- 3018907196
- 3006990600
- 8043971
- 9612030
- 1061124
- 3006581049
- 3004135191
- 1420032
- 3014769442
- 3003435550
- 3030839824
- 1226146
- 3043152784
- 3012460907
- 3010547268
- 3030733800
- 2320762
Source Documents#
Other 510(k) Records For Product Code GCJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |