510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K811277Substantially Equivalent

Cath-Dap

Northwest Alabama Urological Assoc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811277 is the FDA 510(k) clearance record for CATH-DAP, a class II device, cleared for Northwest Alabama Urological Assoc. on under FDA product code KOD (Catheter, Urological). FDA records list one 510(k) clearance for Northwest Alabama Urological Assoc. As of , FDA records show no recalls naming K811277.

Clearance record

Decision date
Received
(73 days to decision)
Product code
KOD Catheter, Urological
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Northwest Alabama Urological Assoc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KOD

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