510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770534Substantially Equivalent

Therapeutic Apparatus, Dierker Type

Well Being Ent., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770534 is the FDA 510(k) clearance record for THERAPEUTIC APPARATUS, DIERKER TYPE, a class II device, cleared for Well Being Ent. on under FDA product code KDH (Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration). FDA records list one 510(k) clearance for Well Being Ent. As of , FDA records show no recalls naming K770534.

Clearance record

Decision date
Received
(396 days to decision)
Product code
KDH Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Well Being Ent. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KDH

Trailing 12 months

FDA records hold no clearances under product code KDH in the trailing twelve months.

FDA records show no clearances under product code KDH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KDH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260