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2-Prong Hook

FDA UDI

Class II (US FDA UDI)

by Gynex Corporation

Identity

Trade Name
2-Prong Hook FDA UDI
Generic Name
Uterine fibroid hook FDA UDI
Model / Reference
3227 FDA UDI

Identifiers

Primary DI / UDI-DI
GYNX32270 FDA UDI
510(k) Number
K980247 FDA UDI
FDA Product Code
HDC FDA UDI
GMDN Term
Uterine fibroid hook FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.4530 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Uterine fibroid hook

2-Prong Hook by Gynex Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Uterine fibroid hook.

Cleared under the same submission

K980247 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gynex Corporation

Sources (1)

  • FDA UDI 99c6d7f1-58c9-48c8-aa7e-783d9d4ea91b 33 fields · synced May 30, 2026