510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K890072Substantially Equivalent

Primrose Female Ext. Cath or Ext. Urinary Drainage

Medireach, Inc., Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890072 is the FDA 510(k) clearance record for PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE, a class II device, cleared for Medireach, Inc. on under FDA product code KNY (Accessories, Catheter, G-U). FDA records list one 510(k) clearance for Medireach, Inc. As of , FDA records show no recalls naming K890072.

Clearance record

Decision date
Received
(154 days to decision)
Product code
KNY Accessories, Catheter, G-U
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Medireach, Inc. 4885 Alpha Rd., Dallas TX
Third party review
No

Clearances, product code KNY

Trailing 12 months
1 clearance under product code KNY in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260