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BiCOAG

FDA UDI

Class II (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name
BiCOAG FDA UDI
Generic Name
Endoscopic electrosurgical electrode, bipolar, single-use FDA UDI
Device Name
10FR FIXEDPIN HEMOSTATIC PROBE FDA UDI
Model / Reference
CD-B612LA FDA UDI
Description
10FR FIXEDPIN HEMOSTATIC PROBE FDA UDI

Identifiers

Primary DI / UDI-DI
00821925039476 FDA UDI
510(k) Number
K123319 FDA UDI
FDA Product Code
KNS FDA UDI
GMDN Term
Endoscopic electrosurgical electrode, bipolar, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4300 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

No

FDA UDI

Category: Endoscopic electrosurgical electrode, bipolar, single-use

BiCOAG by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic electrosurgical electrode, bipolar, single-use.

Cleared under the same submission

K123319 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gyrus Acmi, Inc.

Sources (1)

  • FDA UDI fe1449c6-181a-45ee-bba1-78374171a604 34 fields · synced May 30, 2026