Super X Adjustrette

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K770251 ↗

FDA Product Code

EXD

Device Class

Class II

Regulation

21 CFR Part 876.5895

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• At-2

  Class II

  FDA 510(k) K923007 Active Cleared 26 Feb 1993

• Elegance

  Class I

  FDA 510(k) K812578 Active Cleared 2 Oct 1981

• Acoustic Appraiser CD-2 Audiometer/Master Hear.Aid

  Class II

  FDA 510(k) K904544 Active Cleared 31 Oct 1990

• As-90

  Class I

  FDA 510(k) K923006 Active Cleared 18 Sep 1993

• Compression Multisonic

  Class I

  FDA 510(k) K780241 Active Cleared 17 Feb 1978

• Qualitone Model 48 C-Wr-Behind the Ear

  Class I

  FDA 510(k) K912154 Active Cleared 17 Jun 1991

See all devices from Qualitone →

• What is the SUPER X ADJUSTRETTE used for?

  This device is an Irrigator, Ostomy intended for use in Gastroenterology and Urology procedures.

• Is the SUPER X ADJUSTRETTE sterile?

  The provided data does not specify if the device is sterile.

• Can the SUPER X ADJUSTRETTE be reused?

  No, the device is supplied as a single-use item and is not reusable.

• How is the SUPER X ADJUSTRETTE regulated?

  It is a Class 2 device cleared under the FDA 510(k) pathway with the decision code SESE.