Identity
- Trade Name
- SmartSnare EMR Hexagonal Snare FDA UDI
- Generic Name
- Mechanical-cutting endoscopic polypectomy snare FDA UDI
- Device Name
- SmartSnare EMR Hexagonal Snare supports resection of target pseudopolyp with its ultra-slim snare wire diameter and controlled rotation designed to facilitate placement around the band. FDA UDI
- Model / Reference
- SS-230-1 FDA UDI
- Description
- SmartSnare EMR Hexagonal Snare supports resection of target pseudopolyp with its ultra-slim snare wire diameter and controlled rotation designed to facilitate placement around the band. FDA UDI
Identifiers
- Catalog Number
- SS2301 FDA UDI
- Primary DI / UDI-DI
- 00850261006125 FDA UDI
- 510(k) Number
- K212860 FDA UDI
- FDA Product Code
- FDI FDA UDI
- GMDN Term
- Mechanical-cutting endoscopic polypectomy snare FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 230 Centimeter FDA UDIWidth — 15 Millimeter FDA UDI
Category: Mechanical-cutting endoscopic polypectomy snare
SmartSnare EMR Hexagonal Snare by Intelligent Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mechanical-cutting endoscopic polypectomy snare.
- LesionHunter(TM) Rotatable Nitinol Cold Snare — Micro-Tech (Nanjing) Co., Ltd. · Class I
- Multiple Loop Polypectomy Snare — Avanos Medical, Inc. · Class II
- Optimos™ Snare — Taewoong Medical · Class I
- Disposable Polypectomy Cold Snare — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class I
- LesionHunter(TM) Rotatable Nitinol Cold Snare — Micro-Tech (Nanjing) Co., Ltd. · Class I
- Multiple Loop Polypectomy Snare — Avanos Medical, Inc. · Class II
- CAPTIFLEX — Boston Scientific · Class II
- Lasso — Diversatek Healthcare · Class I
Cleared under the same submission
K212860 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Intelligent Endoscopy
Sources (1)
- FDA UDI d6b28379-bbeb-4b6a-8a3e-9fb385a6c86b 37 fields · synced May 30, 2026