Skip to content

Neoscope NFU 9

by Prosurg, Inc

Neoscope NFU 9 is a flexible video ureteroscope (FDA Class II; FDA product code FAJ, Cystoscope And Accessories, Flexible/Rigid) made by Prosurg, Inc, cleared under FDA 510(k) K120766 on 11 Sep 2012 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00851545007623), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K120766

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00851545007623 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK120766 Date11 Sep 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K120766 decided 11 Sep 2012 Active
  • FDA GUDID UDI-DI 00851545007623 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K120766
  2. Listed FDA GUDID 00851545007623

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Neoscope
Generic name
Flexible video ureteroscope, reusable
Model / reference
NFU 9
Primary DI / UDI-DI
00851545007623
510(k) Number
FDA product code
FAJ
GMDN term
Flexible video ureteroscope, reusable
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 9.0 French

Related devices

Category: Flexible video ureteroscope, reusable

Cleared under the same submission (K120766)

and 8 more cleared under K120766

Similar devices

Other devices filed under FDA product code FAJ (Cystoscope And Accessories, Flexible/Rigid).

Other devices from Prosurg, Inc

See all devices from Prosurg, Inc →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)