510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963858Substantially Equivalent

Femassist Urinary Device

Insight Medical Corp., Bolton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963858 is the FDA 510(k) clearance record for FEMASSIST URINARY DEVICE, a class I device, cleared for Insight Medical Corp. on under FDA product code MNG (External Urethral Occluder, Urinary Incontinence-Control, Female). FDA's definition for product code MNG reads: "Intended to prevent or decrease episodes of urine leakage in women with stress incontinence. Occluder is applied to urinary meatus through suction or tape, which creates a barrier for urine leakage. Occluding device such as a cap, suction...". FDA records list 3 510(k) clearances for Insight Medical Corp., from to . As of , FDA records show no recalls naming K963858.

Clearance record

Decision date
Received
(391 days to decision)
Product code
MNG External Urethral Occluder, Urinary Incontinence-Control, Female
Regulation
21 CFR 876.5160
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Insight Medical Corp. 580 Main St., Bolton MA
510(k) summary
Summary
Third party review
No

Clearances, product code MNG

Trailing 12 months

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

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