Identity
- Trade Name
- Hobbs Medical Polypectomy Snare FDA UDI
- Generic Name
- Flexible polypectomy snare, single-use FDA UDI
- Device Name
- A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single use device. FDA UDI
- Model / Reference
- 4573 FDA UDI
- Description
- A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single use device. FDA UDI
Identifiers
- Catalog Number
- 4573 FDA UDI
- Primary DI / UDI-DI
- M84945730 FDA UDI
- 510(k) Number
- K844074 FDA UDI
- FDA Product Code
- OCZ FDA UDI
- GMDN Term
- Flexible polypectomy snare, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
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
Category: Flexible polypectomy snare, single-use
Hobbs Medical Polypectomy Snare by Hobbs Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible polypectomy snare, single-use.
- PROFILE — Boston Scientific · Class II
- Orbit-Snare — Medi-Globe Corporation · Class II
- Halyard — Avanos Medical, Inc. · Class II
- PROFILE — Boston Scientific · Class II
- Halyard — Avanos Medical, Inc. · Class II
- Halyard — Avanos Medical, Inc. · Class II
- Orbit-Snare — Medi-Globe Corporation · Class II
- Halyard — Avanos Medical, Inc. · Class II
Cleared under the same submission
K844074 also covers:
- Hobbs Medical Polypectomy Snare — HOBBS MEDICAL, INC.
- Hobbs Medical Polypectomy Snare — HOBBS MEDICAL, INC.
- Hobbs Medical Polypectomy Snare — HOBBS MEDICAL, INC.
- Hobbs Medical Polypectomy Snare — HOBBS MEDICAL, INC.
- Hobbs Medical Polypectomy Snare — HOBBS MEDICAL, INC.
- Hobbs Medical Polypectomy Snare — HOBBS MEDICAL, INC.
- Hobbs Medical Polypectomy Snare — HOBBS MEDICAL, INC.
- Hobbs Medical Polypectomy Snare — HOBBS MEDICAL, INC.
- Hobbs Medical Polypectomy Snare — HOBBS MEDICAL, INC.
- Hobbs Medical Polypectomy Snare — HOBBS MEDICAL, INC.
- Hobbs Medical Polypectomy Snare — HOBBS MEDICAL, INC.
- Hobbs Medical Polypectomy Snare — HOBBS MEDICAL, INC.
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
- Hobbs Medical, Inc.
Sources (1)
- FDA UDI 32fc3aff-a5c2-4e2c-9e2e-720eb33056d3 36 fields · synced Jun 8, 2026