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SemiFlex Scope MF-ENDO 65

by Maxiflex, LLC

SemiFlex Scope MF-ENDO 65 is a Class II device made by Maxiflex, LLC, cleared under FDA 510(k) K111480 on 4 Apr 2012 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI B324MFENDO650), active as of 23 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 23 Oct 2026

Documents

510(k) K111480

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB324MFENDO650 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK111480 Date4 Apr 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K111480 decided 4 Apr 2012 Active
  • FDA GUDID UDI-DI B324MFENDO650 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K111480
  2. Listed FDA GUDID B324MFENDO650

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SemiFlex Scope
Generic name
Flexible fibreoptic ureteroscope
Model / reference
MF-ENDO 65
Primary DI / UDI-DI
B324MFENDO650
510(k) Number
FDA product code
FGB
GMDN term
Flexible fibreoptic ureteroscope
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
Sterilisation method
Hydrogen Peroxide
Size
Catheter Gauge — 9.5 French
Length — 65 Centimeter

Related devices

Category: Flexible fibreoptic ureteroscope

Cleared under the same submission (K111480)

and 8 more cleared under K111480

Similar devices

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

Other devices from Maxiflex, LLC

See all devices from Maxiflex, LLC →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Prescription use
  • Serial number
  • Expiration date
Other properties (9, all answered No)