10k

FDA UDIEUDAMED

Class II (US FDA UDI)

by Conmed Corporation

Identity

Trade Name: 10K FDA UDI
Generic Name: Arthroscopic irrigation/insufflation system FDA UDI
Device Name: IRRIGATION CONSOLE 10K FDA UDI
Model / Reference: 10K FDA UDI
Description: IRRIGATION CONSOLE 10K FDA UDI

Identifiers

Catalog Number: 10K FDA UDI
Primary DI / UDI-DI: 10845854041109 FDA UDI
FDA Product Code: HRX FDA UDI
GCJ FDA UDI
GMDN Term: Arthroscopic irrigation/insufflation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.1100 FDA UDI
876.1500 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Arthroscopic irrigation/insufflation system

10k by Conmed Corporation — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Arthroscopic irrigation/insufflation system.

Arthrex® — Arthrex, Inc. · Class I
Arthrex® — Arthrex, Inc. · Class II
FMS VUE II — Medos International Sàrl · Class II
GoFlo Pump — W.O.M. World of Medicine GmbH · Class II
SHAVER INTERFACE — Biomet Orthopedics, Inc. · Class I
Coblation — Smith & Nephew, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class I
GoFlo Pump — W.O.M. World of Medicine GmbH · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Conmed Corporation

Sources (2)

FDA UDI c1a8ad58-ec56-42e4-9416-3e2f3eaef25c 36 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced Jun 1, 2026