510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001576Substantially Equivalent

Eva -Vacuum Assist Device for Clitoral Therapy

Prosurg, Inc, San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001576 is the FDA 510(k) clearance record for EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY, a class II device, cleared for Prosurg, Inc. on under FDA product code NBV (Device, Engorgement, Clitoral). FDA records list 16 510(k) clearances for Prosurg, Inc., from to . As of , FDA records show no recalls naming K001576.

Clearance record

Decision date
Received
(220 days to decision)
Product code
NBV Device, Engorgement, Clitoral
Regulation
21 CFR 884.5970
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Prosurg, Inc. 2193 Trade Zone Blvd., San Jose CA
510(k) summary
Statement
Third party review
No

Clearances, product code NBV

Trailing 12 months

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

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