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Neoscope NFC 17

by Prosurg, Inc

Neoscope NFC 17 is a flexible video cystoscope (FDA Class II; FDA product code FAS, Electrode, Electrosurgical, Active, Urological) 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 00851545007548), 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 Number00851545007548 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 00851545007548 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K120766
  2. Listed FDA GUDID 00851545007548

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  • Withdrawn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 cystoscope, single-use
Model / reference
NFC 17
Primary DI / UDI-DI
00851545007548
510(k) Number
FDA product code
FAS
GMDN term
Flexible video cystoscope, single-use
Device class
Class II
Regulation number
876.4300
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 17 French

Similar devices in this category

Other devices filed under Flexible video cystoscope, single-use.

Other devices from Prosurg, Inc

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Properties

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