Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020712480

FEI Number

3020712480

Entity Name

ERBE MEDICAL, LLC

City/State/Country

Tempe, AZ, US

Establishment Address

405 W Geneva Dr, Tempe, AZ 85282, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Erbe Medical, LLC (Owner Number: 10083032)

Owner / Operator Contact Address

405 W Geneva Dr, Tempe, AZ 85282, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162152

PMA Number

N/A

All Registered Proprietary Names

Endo QuickConnect Pentax® Scope Port Connector ERBEFLO® 2 Back Flow Valve ERBEFLO® 2 Endoscopy Port Connector w/Valve for Olympus Scopes ERBEFLO® 2 Endoscopy Channel Adapter ERBEFLO® 2 Endoscopy Pump Tubing/Cap Set for Fujinon Scopes ERBEFLO® 2 Endoscopy Port Connector for Olympus Scopes ERBEFLO® 2 Endoscopy Pump Tubing/Cap Set ERBEFLO® 2 Endoscopy OFP & EndoStat Pump Tubing/Cap Set ERBEFLO® 2 Endoscopy Port Connector for Pentax Scopes ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Set for Olympus® Scopes & CO2 Sources ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Set for Pentax® Scopes ERBEFLO AeroRinse® CO2 and Water Tubing/Cap Set for Fujinon® Scopes ERBEFLO AeroRinse® CO2 and Water Tubing/Cap Set for Olympus® Scopes & UCR ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Set for Fujinon® Scopes ERBEFLO AeroRinse® CO2 and Water Tubing/Cap Set for Pentax® Scopes ERBEFLO AeroRinse® CO2 and Water Tubing/Cap Set for Olympus® Scopes ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Set for Olympus® Scopes & UCR ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Set for Fujifilm® Scopes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2021-10-20
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2021-10-20
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2023-09-19

Official Correspondent

Kyle Donnelly

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Erbe Medical, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
Z-0011-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020712480. Last updated year: 2026. Please use registration number 3020712480 when referencing this establishment in official correspondence.