510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K861858Substantially Equivalent

Vaginal Chamber Pellethane-Medical Grade 2363

Peritone Research, Ltd., Bellerose NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861858 is the FDA 510(k) clearance record for VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363, a class II device, cleared for Peritone Research, Ltd. on under FDA product code HIR (Perineometer). FDA records list 2 510(k) clearances for Peritone Research, Ltd., from to . As of , FDA records show no recalls naming K861858.

Clearance record

Decision date
Received
(78 days to decision)
Product code
HIR Perineometer
Regulation
21 CFR 884.1425
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Peritone Research, Ltd. 75-04 249 St., Bellerose NY
Third party review
No

Clearances, product code HIR

Trailing 12 months
1 clearance under product code HIR in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HIR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260