510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K181124Substantially Equivalent

Acessa ProVu System

Acessa Health, Inc., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K181124 is the FDA 510(k) clearance record for Acessa ProVu System, a class II device, cleared for Acessa Health, Inc. on under FDA product code HFG (Coagulator, Laparoscopic, Unipolar (And Accessories)). FDA records list one 510(k) clearance for Acessa Health, Inc. As of , FDA records show no recalls naming K181124.

Clearance record

Decision date
Received
(151 days to decision)
Product code
HFG Coagulator, Laparoscopic, Unipolar (And Accessories)
Regulation
21 CFR 884.4160
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Acessa Health, Inc. 7004 Bee Cave Rd., Bldg. 3, Suite 200, Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HFG

Trailing 12 months

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

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