510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K090430Substantially Equivalent

Backstop and Backstop Injector

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

K090430 is the FDA 510(k) clearance record for BACKSTOP AND BACKSTOP INJECTOR, a class II device, cleared for Pluromed, Inc. on under FDA product code ONJ (Dissolvable Gel For Preventing Ureteral Stone Migration). FDA's definition for product code ONJ reads: "For use in the ureter to prevent the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures". FDA records list 4 510(k) clearances for Pluromed, Inc., from to . As of , FDA records show no recalls naming K090430.

Clearance record

Decision date
Received
(103 days to decision)
Product code
ONJ Dissolvable Gel For Preventing Ureteral Stone Migration
Regulation
21 CFR 876.4680
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 ONJ

Trailing 12 months

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

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