510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970021Substantially Equivalent

Rusch Suprapubic Tray

Rusch, Inc., Jeffrey NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970021 is the FDA 510(k) clearance record for RUSCH SUPRAPUBIC TRAY, a class II device, cleared for Rusch, Inc. on under FDA product code KOB (Catheter, Suprapubic (And Accessories)). FDA records list 20 510(k) clearances for Rusch, Inc., from to . As of , FDA records show no recalls naming K970021.

Clearance record

Decision date
Received
(35 days to decision)
Product code
KOB Catheter, Suprapubic (And Accessories)
Regulation
21 CFR 876.5090
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Rusch, Inc. Tall Pines Park, Jeffrey NH
510(k) summary
Summary
Third party review
No

Clearances, product code KOB

Trailing 12 months

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

FDA records show no clearances under product code KOB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KOB, 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