Kirwan

FDA UDI

Class II (US FDA UDI)

by Kirwan Surgical Products Llc

Identity

Trade Name: Kirwan FDA UDI
Generic Name: Electrosurgical cable adaptor FDA UDI
Device Name: Monopolar Plug Adapter 4mm Banana Plug to Standard Bovie Type Plug FDA UDI
Model / Reference: 30-5105 FDA UDI
Description: Monopolar Plug Adapter 4mm Banana Plug to Standard Bovie Type Plug FDA UDI

Identifiers

Primary DI / UDI-DI: 00841019108086 FDA UDI
510(k) Number: K895337 FDA UDI
FDA Product Code: HAM FDA UDI
GMDN Term: Electrosurgical cable adaptor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Electrosurgical cable adaptor

Kirwan by Kirwan Surgical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K895337 also covers:

Sense Medical — SENSE MEDICAL LLC

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: Kirwan Surgical Products Llc

Sources (1)

FDA UDI 9d0bf405-ce59-47d1-9c10-1dcb0dce1100 35 fields · synced May 31, 2026