Atlas FDA

SNARE, FLEXIBLE, ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES

FDA 510(k) clearance K950496 · decided 1995-03-30

Clearance details

K-number
K950496
Device name
SNARE, FLEXIBLE, ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
Applicant
Boston Scientific Corp
Decision
Substantially Equivalent
Date received
1995-02-06
Decision date
1995-03-30
Days to decision
52 days
Clearance type
Traditional
Product code
FDI
Device class
2
Regulation number
876.4300
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Watertown, MA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Boston Scientific Corp

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Advanced Tissue Resection Device (K251692)Micro-Tech (Nanjing) Co., Ltd.2026-02-21
Polypectomy Snare (K221713)Hangzhou AGS MedTech Co., Ltd.2023-03-03
CORE-SNARE (K220846)Incore Co., Ltd.2022-11-21
Disposable Polyp Snare (K220089)Jiangsu Vedkang Medical Science and Technology Co., Ltd.2022-09-22
Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare (K220790)Yangzhou Fartley Medical Instrument Technology Co., Ltd.2022-06-27
Disposable Polypectomy Snare (K213222)Beijing Zksk Technology Co., Ltd.2022-06-06
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) (K212860)STERIS Corporation2021-10-07
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares (K202478)Boston Scientific Corporation2020-10-08
Lariat, Hot/Cold Snare (K200745)United States Endoscopy Group, Inc.2020-04-21
SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare (K190512)Intelligent Endoscopy2019-11-22
AcuSnare Polypectomy Snare - Duckbill (K191048)Wilson-Cook Medical, Inc.2019-07-18
ClearGrasp Snare (K183289)Finemedix Co., Ltd.2019-03-06

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ALTRUA™ 2 (Models S701, S702, S722) ESSENTIO™ (Models L100, L101, L121) PROPONENT™ (Models L200, L201, L221) ACCOLADE™ ( (N970003/S304)Boston Scientific Corp2025-12-19
WaveWriter Alpha Spinal Cord Stimulator (SCS) Mixed Systems, M8 Adaptor (P030017/S374)Boston Scientific Corp2025-12-18
WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S082)Boston Scientific Corp2025-12-18
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S090)Boston Scientific Corp2025-12-17
ALTRUA™ 2 (Model S722); ESSENTIO™ (Model L121); PROPONENT™ (Model L221); ACCOLADE™ (Model L321) (N970003/S305)Boston Scientific Corp2025-12-17
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S390)Boston Scientific Corp2025-12-17
WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device with Delivery System (P130013/S079)Boston Scientific Corp2025-12-15
WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device with Delivery System (P130013/S078)Boston Scientific Corp2025-12-15