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Hobbs Medical Polypectomy Snare

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K844074

by Hobbs Medical, Inc.

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
4560OLY 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
4560OLY FDA UDI
Primary DI / UDI-DI
M8494560OLY0 FDA UDI
510(k) Number
K844074 FDA 510(k)FDA UDI
FDA Product Code
OCZ FDA 510(k)FDA UDI
GMDN Term
Flexible polypectomy snare, single-use FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)FDA UDI
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

Hobbs Medical Polypectomy Snare by Hobbs Medical, Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hobbs Medical, Inc.

Sources (2)

  • FDA 510(k) K844074 24 fields · synced Jun 18, 2026
  • FDA UDI ee256b9a-bf30-43df-8422-79358a95f2b0 36 fields · synced May 27, 2026