510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103349Substantially Equivalent

Backstop Catheter

Pluromed, Inc., Woburn MA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103349 is the FDA 510(k) clearance record for BACKSTOP CATHETER, a class II device, cleared for Pluromed, Inc. on under FDA product code KOD (Catheter, Urological). FDA records list 4 510(k) clearances for Pluromed, Inc., from to . As of , FDA records show no recalls naming K103349.

Clearance record

Decision date
Received
(52 days to decision)
Product code
KOD Catheter, Urological
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Pluromed, Inc. 25-H Olympia Ave., Woburn MA
510(k) summary
Summary PDF
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