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Gomco Type Circumcision Clamp

FDA UDI

Class II (US FDA UDI)

by Fine Surgical Instruments Inc.

Identity

Trade Name
Gomco Type Circumcision Clamp FDA UDI
Generic Name
Circumcision clamp, single-use FDA UDI
Device Name
Gomco Type Circumcision Clamp Disposable Chrome Plated, NB 1.3cm FDA UDI
Model / Reference
28-855 FDA UDI
Description
Gomco Type Circumcision Clamp Disposable Chrome Plated, NB 1.3cm FDA UDI

Identifiers

Catalog Number
28-855 FDA UDI
Primary DI / UDI-DI
00869401000213 FDA UDI
510(k) Number
K040052 FDA UDI
FDA Product Code
HFX FDA UDI
GMDN Term
Circumcision clamp, single-use 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

Yes

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
MRI Safety
MR Unsafe FDA UDI

Category: Circumcision clamp, single-use

Gomco Type Circumcision Clamp by Fine Surgical Instruments Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Circumcision clamp, single-use.

Cleared under the same submission

K040052 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fine Surgical Instruments Inc.

Sources (1)

  • FDA UDI 1b90bdd8-54f3-4afd-bc65-3b4845f0cb2b 37 fields · synced May 30, 2026