Aed 32-4095

• FDA 510(k) K993689 decided 15 Dec 1999 Active
• FDA GUDID UDI-DI 00848657019668 listed 28 Nov 2017 Listed

1. 15 Dec 1999 Cleared FDA 510(k) K993689
2. 28 Nov 2017 Listed FDA GUDID 00848657019668

Trade name

Aed

Generic name

Rigid optical cystoscope

Model / reference

32-4095

Primary DI / UDI-DI

00848657019668

510(k) Number

K993689 ↗

FDA product code

FAJ

GMDN term

Rigid optical cystoscope

Device class

Class II

Regulation number

876.1500

GUDID distribution status

In Commercial Distribution

Sterilisation method

Moist Heat or Steam Sterilization

Category: Rigid optical cystoscope

Other devices filed under FDA product code FAJ (Cystoscope and accessories, flexible/rigid).

• OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413) by Olympus Medical Systems Corporation
• ENDO SMARTCAP 100160 by MEDIVATORS INC.
• Uro-G HD Flexible Cystoscope by UroViu Corporation
• ENDO SMARTCAP by Byrne Medical, Inc.
• IMAGYN UROSCOPE by Imagyn Medical, Inc.
• WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet by OTU MEDICAL INC.
• MEDIFIX INC. by Medifix, Inc.
• ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 by Acmi Corporation
• ENDO SMARTCAP 100150 by MEDIVATORS INC.
• CURITY ECONOMY II CYSTOSCOPY TRAY by The Kendal Co.

• Aed AED2718B

  Class II

  FDA 510(k) K993689 Active Cleared 15 Dec 1999 GUDID on market

• Aed AED2717B

  Class II

  FDA 510(k) K993689 Active Cleared 15 Dec 1999 GUDID on market

• Aed AED2719B

  Class II

  FDA 510(k) K993689 Active Cleared 15 Dec 1999 GUDID on market

• Aed 8815SB

  Class II

  FDA 510(k) K993688 Active Cleared 6 Dec 1999 GUDID on market

See all devices from National Advanced Endoscopy Devices, Inc. →