510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K002617Substantially Equivalent

Periform Perineometric Probe, Model 8300

Neen Design, Ltd., Dereham, Norfolk, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002617 is the FDA 510(k) clearance record for PERIFORM PERINEOMETRIC PROBE, MODEL 8300, a class II device, cleared for Neen Design , Ltd. on under FDA product code HIR (Perineometer). FDA records list one 510(k) clearance for Neen Design , Ltd. As of , FDA records show no recalls naming K002617.

Clearance record

Decision date
Received
(225 days to decision)
Product code
HIR Perineometer
Regulation
21 CFR 884.1425
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Neen Design , Ltd. Old Pharmacy Yard, Church St., Dereham, Norfolk, GB
510(k) summary
Summary
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