510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN130047Unknown

Prolong

Ergon Medical, Ltd., West Sussex, GB / Direct, Unknown
FDA source (opens on fda.gov)

DEN130047 is the FDA 510(k) clearance record for PROLONG, a class II device, cleared for Ergon Medical , Ltd. on under FDA product code PIA (Vibrator For Climax Control Of Premature Ejaculation). FDA's definition for product code PIA reads: "Vibrator for climax control training for the treatment of premature ejaculation". FDA records list one 510(k) clearance for Ergon Medical , Ltd. As of , FDA records show no recalls naming DEN130047.

Clearance record

Decision date
Received
(487 days to decision)
Product code
PIA Vibrator For Climax Control Of Premature Ejaculation
Regulation
21 CFR 876.5025
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Ergon Medical , Ltd. 25 Barker Close, West Sussex, GB
Third party review
No

Clearances, product code PIA

Trailing 12 months

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

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