510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101847Substantially Equivalent

Urgent Pc Stimulator; Urgent Pc Lead Set

Uroplasty, LLC, Minnetonka MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101847 is the FDA 510(k) clearance record for URGENT PC STIMULATOR; URGENT PC LEAD SET, a class II device, cleared for Uroplasty, Inc. on under FDA product code NAM (Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence). FDA records list 8 510(k) clearances for Uroplasty, Inc., from to . As of , FDA records show no recalls naming K101847.

Clearance record

Decision date
Received
(112 days to decision)
Product code
NAM Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
Regulation
21 CFR 876.5310
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Uroplasty, Inc. 5420 Feltl Rd., Minnetonka MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NAM

Trailing 12 months

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

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