Prosurg

FDA UDI

Class II (US FDA UDI)

by Prosurg, Inc

Identity

Trade Name: Prosurg FDA UDI
Generic Name: Flexible video cystoscope, single-use FDA UDI
Device Name: Neoflex Cystoscope 15FR FDA UDI
Model / Reference: NFC15 FDA UDI
Description: Neoflex Cystoscope 15FR FDA UDI

Identifiers

Catalog Number: NFC15 FDA UDI
Primary DI / UDI-DI: 00851545007739 FDA UDI
510(k) Number: K120766 FDA UDI
FDA Product Code: FAJ FDA UDI
GMDN Term: Flexible video cystoscope, 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

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Flexible video cystoscope, single-use

Prosurg by Prosurg, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible video cystoscope, single-use.

Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
VersaVue Tablet - Global/CE Demo — MEDIMAGING INTEGRATED SOLUTION INC. · Class II
Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
Aptra — OTU MEDICAL INC. · Class II
Uro-G Flexible Cystoscope — UroViu Corporation · Class II
VersaVue Tablet Power Cord – QA/LB/JO — MEDIMAGING INTEGRATED SOLUTION INC. · Class II

Cleared under the same submission

K120766 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Prosurg, Inc

Sources (1)

FDA UDI 4d194380-8b54-4a9c-ad6b-1d5eed7418ee 35 fields · synced Jun 8, 2026