SemiFlex Scope MF-ENDO 60
SemiFlex Scope MF-ENDO 60 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 B324MFENDO600), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB324MFENDO600 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK111480 | Date4 Apr 2012 | StatusActive |
Official records
- FDA 510(k) database K111480
Across registries
- FDA 510(k) K111480 decided 4 Apr 2012 Active
- FDA GUDID UDI-DI B324MFENDO600 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K111480
- Listed FDA GUDID B324MFENDO600
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SemiFlex Scope
- Generic name
- Flexible fibreoptic ureteroscope
- Model / reference
- MF-ENDO 60
- Primary DI / UDI-DI
- B324MFENDO600
- 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
- Length — 60 CentimeterCatheter Gauge — 9.5 French
Similar devices
Other devices filed under FDA product code FGB (Ureteroscope And Accessories, Flexible/Rigid).
- Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) by Opcom Medical, Inc.
- Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9) by Guangzhou Red Pine Medical Instrument Co.,Ltd.
- E-LINE 8701534 8701.534 by Richard Wolf GmbH
- SURGITEK GRADUATED URETEROSCOPE (MODEL GU-8) by Surgitek
- Gyrus ACMI CS-W7S by Gyrus Acmi, Inc.
- LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope -– Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Reverse (without pressure monitoring) (M0067941500) by Boston Scientific
- KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE by Karl Storz Endoscopy
- F88 URE-SD/RD Flexible Ureteroscope by Sg Endoscopy Pte, Ltd.
- 12 URETEROSCOPES/URETERO-RENOSCOPES by RICHARD WOLF MEDICAL INSTRUMENTS CORP.
- MEDIFIX URETEROSCOPE by Medifix, Inc.