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510(k) K181124

Acessa ProVu System by Acessa Health, Inc. — Product Code HFG

K181124 is an FDA 510(k) premarket notification submitted by Acessa Health, Inc. for the device "Acessa ProVu System". The FDA issued a decision of Substantially Equivalent on September 28, 2018. The device falls under product code HFG (Coagulator, Laparoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2018
Date Received
April 30, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator, Laparoscopic, Unipolar (And Accessories)
Device Class
Class II
Regulation Number
884.4160
Review Panel
OB
Submission Type

Other clearances for product code HFG

  • K132744 — ACESSA GUIDANCE SYSTEM (May 27, 2014)
  • K132184 — ACESSA GUIDANCE HANDPIECE (April 28, 2014)
  • K121858 — THE ABLATION SYSTEM (November 5, 2012)
  • K101606 — MICROMED PD-8K INSULATION DEFECT DETECTOR (October 1, 2010)
  • K991424 — INSULSCAN INSULATION TESTING SYSTEM (July 22, 1999)
  • K961695 — ENDO-TECH LTD., TIPS (July 1, 1996)
  • K921405 — DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP (March 25, 1994)
  • K915406 — DAVOL ELECTROSUGICAL PROBES (February 28, 1992)
  • K904240 — SINGLE USE LAPARSCOPIC ELECTRODE (February 19, 1991)
  • K902555 — AMCATH COAGULATION PROBE (June 20, 1990)

FDA data resources