510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K935090Substantially Equivalent

Cuff-Cath

GE Healthcare, Washington, D.C. DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935090 is the FDA 510(k) clearance record for CUFF-CATH, a class II device, cleared for Ohmeda Medical on under FDA product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K935090.

Clearance record

Decision date
Received
(357 days to decision)
Product code
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Ohmeda Medical Columbia Sq., Washington, D.C. DC
510(k) summary
Summary
Third party review
No

Clearances, product code FOZ

Trailing 12 months
8 clearances under product code FOZ in the twelve months to November 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FOZ, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20262
May 20261
June 20260
July 20262
August 20261
September 20261
October 20260
November 20260