510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K993651Substantially Equivalent

O'neil Sterile Field Intermittent Urinary Catheter

Sc Hennig Enterprises Europe SRL, Western Australia, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993651 is the FDA 510(k) clearance record for O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER, a class II device, cleared for Sc Hennig Enterprises Europe Srl on under FDA product code GBM (Catheter, Urethral). FDA records list one 510(k) clearance for Sc Hennig Enterprises Europe Srl. As of , FDA records show no recalls naming K993651.

Clearance record

Decision date
Received
(55 days to decision)
Product code
GBM Catheter, Urethral
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Sc Hennig Enterprises Europe Srl 25 Shann St., Western Australia, AU
510(k) summary
Statement
Third party review
No

Clearances, product code GBM

Trailing 12 months

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

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