Endosee System

FDA UDI

Class II (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name: Endosee System FDA UDI
Generic Name: Flexible fibreoptic hysteroscope FDA UDI
Device Name: Endosee Display Module, Docking Station, power cord, USB cable FDA UDI
Model / Reference: ES9000 FDA UDI
Description: Endosee Display Module, Docking Station, power cord, USB cable FDA UDI

Identifiers

Primary DI / UDI-DI: 00888937022018 FDA UDI
510(k) Number: K183020 FDA UDI
FDA Product Code: FAJ FDA UDI
HIH FDA UDI
GMDN Term: Flexible fibreoptic hysteroscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
884.1690 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

FDA UDI

Category: Flexible fibreoptic hysteroscope

Endosee System by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible fibreoptic hysteroscope.

OES HYSTEROFIBERSCOPE — Olympus Medical Systems Corporation · Class II
LUMINELLE DTx Hysteroscopy System — Uvision360, Inc. · Class II
Luminelle DTx Control Hub — Uvision360, Inc. · Class II
Uvision Hysteroscope Cable — Uvision360, Inc. · Class II
OES HYSTEROFIBERSCOPE — Olympus Medical Systems Corporation · Class II
Endosee — CooperSurgical, Inc. · Class II
Endosee — CooperSurgical, Inc. · Class II
Endosee System Convenience Kit — CooperSurgical, Inc.

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: CooperSurgical, Inc.

Sources (1)

FDA UDI 7aa303bd-4b44-4d2e-9cdd-654ee83fb93b 34 fields · synced Jun 9, 2026