510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963950Substantially Equivalent

Bioderm Eid Male External Incontinence Device

Bioderm, Inc., East Burnswick NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963950 is the FDA 510(k) clearance record for BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE, a class I device, cleared for Bioderm, Inc. on under FDA product code EXI (Device, Paste-On For Incontinence, Sterile). FDA records list 14 510(k) clearances for Bioderm, Inc., from to . As of , FDA records show no recalls naming K963950.

Clearance record

Decision date
Received
(100 days to decision)
Product code
EXI Device, Paste-On For Incontinence, Sterile
Regulation
21 CFR 876.5250
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Bioderm, Inc. 29 Ainsworth Ave., East Burnswick NJ
510(k) summary
Summary
Third party review
No

Clearances, product code EXI

Trailing 12 months

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

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