Total Abscession

FDA UDI

Class II (US FDA UDI)

by Angiodynamics, Inc

Identity

Trade Name: Total Abscession FDA UDI
Generic Name: Biliary drain FDA UDI
Device Name: 10F x 40cm Total Abscession Biliary Drainage Catheter (Locking Pigtail) FDA UDI
Model / Reference: H787140009020 FDA UDI
Description: 10F x 40cm Total Abscession Biliary Drainage Catheter (Locking Pigtail) FDA UDI

Identifiers

Catalog Number: 14000902 FDA UDI
Primary DI / UDI-DI: 15051684011686 FDA UDI
510(k) Number: K170743 FDA UDI
FDA Product Code: FGE FDA UDI
GMDN Term: Biliary drain FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5010 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Catheter Gauge — 10 French FDA UDI
Length — 40 Centimeter FDA UDI

Category: Biliary drain

Total Abscession by Angiodynamics, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cook — COOK INCORPORATED · U

Cleared under the same submission

K170743 also covers:

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: Angiodynamics, Inc

Sources (1)

FDA UDI e94c254d-887f-4069-a60a-4740f9b84695 38 fields · synced Jun 20, 2026