510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983325Substantially Equivalent

In-Probe II Urodynamic System

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

K983325 is the FDA 510(k) clearance record for IN-PROBE II URODYNAMIC SYSTEM, a class II device, cleared for Influence, Inc. on under FDA product code FEN (Device, Cystometric, Hydraulic). FDA records list 16 510(k) clearances for Influence, Inc., from to . As of , FDA records show no recalls naming K983325.

Clearance record

Decision date
Received
(63 days to decision)
Product code
FEN Device, Cystometric, Hydraulic
Regulation
21 CFR 876.1620
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Influence, Inc. 71 Stevenson St., Suite 1120, San Francisco CA
510(k) summary
Summary
Third party review
No

Clearances, product code FEN

Trailing 12 months

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

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