ERBEFLO CleverCap®

FDA UDI

Class II (US FDA UDI)

by Erbe Medical, LLC

Identity

Trade Name: ERBEFLO CleverCap® FDA UDI
Generic Name: Endoscopic insufflation tubing set, single-use FDA UDI
Device Name: Hybrid CO2 Tubing/Cap Set for Pentax® Scopes FDA UDI
Model / Reference: 20325-207 FDA UDI
Description: Hybrid CO2 Tubing/Cap Set for Pentax® Scopes FDA UDI

Identifiers

Catalog Number: 20325-207 FDA UDI
Primary DI / UDI-DI: 04065655000689 FDA UDI
510(k) Number: K162152 FDA UDI
FDA Product Code: FEQ FDA UDI
GMDN Term: Endoscopic insufflation tubing set, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 3.5 Meter FDA UDI

Category: Endoscopic insufflation tubing set, single-use

ERBEFLO CleverCap® by Erbe Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Endoscopic insufflation tubing set, single-use.

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ENDO SMARTCAP — MEDIVATORS INC. · Class II
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Steris — Canadian Hospital Specialties Limited · Class I

Cleared under the same submission

K162152 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: Erbe Medical, LLC

Sources (1)

FDA UDI 302461f2-ea74-42e5-9240-2b0f78ea8b5f 38 fields · synced May 30, 2026