510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212495Substantially Equivalent

Leva Pelvic Health System

Renovia, Inc., Boston MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212495 is the FDA 510(k) clearance record for Leva Pelvic Health System, a class II device, cleared for Renovia, Inc. on under FDA product code HIR (Perineometer). FDA records list 4 510(k) clearances for Renovia, Inc., from to . As of , FDA records show no recalls naming K212495.

Clearance record

Decision date
Received
(30 days to decision)
Product code
HIR Perineometer
Regulation
21 CFR 884.1425
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Renovia, Inc. 263 Summer St., 5th Floor, Boston MA
510(k) summary
Summary PDF
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