510(k) K131700
- Device
- SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES
- Applicant
- BOSTON SCIENTIFIC CORP.
- 510(k) number
- K131700
- Product code
- FDI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-11-04
- Date received
- 2013-06-11
- Regulation
- 876.4300
- Classification name
- Snare, Flexible
- 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
- JANIS F TARANTO
- Address
- 100 Boston Scientific Way Marlboro MA US 01752 01752
FDA Registration Numbers#
- 3014769442
- 1064858
- 3007695959
- 1721686
- 3006546082
- 3009888344
- 3011270181
- 3011193403
- 2528981
- 3004083736
- 3004837686
- 3003780911
- 1223925
- 3010288205
- 3011146996
- 1320894
- 2246552
- 1222168
- 3012042439
- 3008720584
- 3010273872
- 2183446
- 3009217531
- 3005099803
- 3002807314
- 9611283
- 9610877
- 3007305485
- 3004129994
- 3008040402
- 3005987240
- 1000121056
- 3007738736
- 1825146
- 3010707607
- 1037905
- 9614641
- 3011050570
- 8010047
- 3021023752
- 1000393132
- 9610617
- 3003782610
- 3010202439
- 3014620201
- 3013526170
- 1047843
- 1643817
- 3023102955
- 2020550
- 9680809
- 3004784537
- 1820334
- 3014342096
- 3013460719
- 1528319
- 3013440400
- 3012494290
- 3017390965
- 3035434483
- 9681260
- 3006696607
- 1225687
Source Documents#
Other 510(k) Records For Product Code FDI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251692 | Advanced Tissue Resection Device | Micro-Tech (Nanjing) Co., Ltd. | 2026-02-21 |
| K221713 | Polypectomy Snare | Hangzhou AGS MedTech Co., Ltd. | 2023-03-03 |
| K220846 | CORE-SNARE | Incore Co., Ltd. | 2022-11-21 |
| K220089 | Disposable Polyp Snare | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2022-09-22 |
| K220790 | Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-06-27 |
| K213222 | Disposable Polypectomy Snare | Beijing Zksk Technology Co., Ltd. | 2022-06-06 |
| K212860 | SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit) | STERIS Corporation | 2021-10-07 |
| K202478 | Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares | Boston Scientific Corporation | 2020-10-08 |
| K200745 | Lariat, Hot/Cold Snare | United States Endoscopy Group, Inc. | 2020-04-21 |
| K190512 | SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare | Intelligent Endoscopy | 2019-11-22 |
| K191048 | AcuSnare Polypectomy Snare - Duckbill | Wilson-Cook Medical, Inc. | 2019-07-18 |
| K183289 | ClearGrasp Snare | Finemedix Co., Ltd. | 2019-03-06 |
| K182909 | Roth Net Retriever Product Line | United States Endoscopy Group, Inc. | 2018-11-21 |
| K173673 | AcuSnare Polypectomy Snare | Wilson-Cook Medical, Inc. | 2018-08-24 |
| K172729 | Polypectomy Snare | Hangzhou AGS MedTech Co., Ltd. | 2018-05-21 |
Legacy Summary#
summary
FDA Review#
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