510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971992Substantially Equivalent

Uromed Alternative Bladder Control Continence Device(abcpn-0026)

Uromed Corp., Needham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971992 is the FDA 510(k) clearance record for UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026), a class I device, cleared for Uromed Corp. on under FDA product code FHA (Clamp, Penile). FDA records list 10 510(k) clearances for Uromed Corp., from to . As of , FDA records show no recalls naming K971992.

Clearance record

Decision date
Received
(64 days to decision)
Product code
FHA Clamp, Penile
Regulation
21 CFR 876.5160
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Uromed Corp. 64 A St., Needham MA
510(k) summary
Summary
Third party review
No

Clearances, product code FHA

Trailing 12 months

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

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