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510(k) K770251

SUPER X ADJUSTRETTE by Qualitone — Product Code EXD

K770251 is an FDA 510(k) premarket notification submitted by Qualitone for the device "SUPER X ADJUSTRETTE". The FDA issued a decision of Substantially Equivalent on February 28, 1977. The device falls under product code EXD (Irrigator, Ostomy), a Class II device regulated under 21 CFR 876.5895. Qualitone has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1977
Date Received
February 9, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Irrigator, Ostomy
Device Class
Class II
Regulation Number
876.5895
Review Panel
GU
Submission Type

Other clearances by Qualitone

  • K961827 — IN-THE-EAR (July 3, 1996)
  • K955466 — DYNAMEQ-II OPTION (February 13, 1996)
  • K955359 — CYBER III OPTION UM, UC312, UC10, UCIC (December 19, 1995)
  • K953884 — PROPHET (October 27, 1995)
  • K941107 — THE CANAL (C.I.C.) AKA/HIDDEN EAR (August 9, 1994)
  • K935348 — ODYSSEY CLINICAL AUDIOMETER (February 9, 1994)
  • K935289 — PRO FIT-CYBER II OPTION (December 22, 1993)
  • K923006 — AS-90 (September 18, 1993)
  • K923007 — AT-2 (February 26, 1993)
  • K923986 — CYBERNETIC OPTION (CYBER I) (September 10, 1992)

Other clearances for product code EXD

  • K121833 — OSTOMY IRRIGATION SET (July 16, 2012)
  • K914692 — URINARY DIVERSION EVACUATING CATHETER (July 2, 1992)
  • K904586 — PALEX IRRIGATION SET (December 28, 1990)
  • K871791 — BLOXOM IRRIGATOR (May 20, 1987)
  • K840268 — IRRIGATION SYSTEM (April 5, 1984)
  • K832299 — VISI-FLOW IRRIGATOR (August 26, 1983)
  • K823274 — UNI-TIP COLOSTOMY IRRIGATION CONE (December 7, 1982)
  • K811160 — SUR-FIT IRRIGATION SLEEVE (June 2, 1981)
  • K790749 — COLOSTOMY ENEMA DEVICE (May 16, 1979)
  • K790750 — COLOSTOMY DEVICE W/ PRESSURE LID (May 14, 1979)

FDA data resources