510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K002834Substantially Equivalent

Srs Vaginal Emg/stimulation Perineometer Sensor Srs Anal Emg/stimulation Perineometer Sensor

Srs Medical Systems, Inc., Redmond WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002834 is the FDA 510(k) clearance record for SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR, a class II device, cleared for Srs Medical Systems, Inc. on under FDA product code HIR (Perineometer). FDA records list 3 510(k) clearances for Srs Medical Systems, Inc., from to . As of , FDA records show no recalls naming K002834.

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
Srs Medical Systems, Inc. 14950 NE 95th St., Redmond WA
510(k) summary
Statement
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