510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K863792Substantially Equivalent

Duracath, Gish Model No. Dvac-Xxxx

Gish Biomedical, Inc., Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863792 is the FDA 510(k) clearance record for DURACATH, GISH MODEL NO. DVAC-XXXX, a class II device, cleared for Gish Biomedical, Inc. on under FDA product code BSO (Catheter, Conduction, Anesthetic). FDA records list 75 510(k) clearances for Gish Biomedical, Inc., from to . As of , FDA records show no recalls naming K863792.

Clearance record

Decision date
Received
(70 days to decision)
Product code
BSO Catheter, Conduction, Anesthetic
Regulation
21 CFR 868.5120
Device class
Class II
Review panel
Anesthesiology
Applicant
Gish Biomedical, Inc. 2350 S. Pullman Ave., Santa Ana CA
Third party review
No

Clearances, product code BSO

Trailing 12 months

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

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