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510(k) K132744

ACESSA GUIDANCE SYSTEM by Halt Medical, Inc. — Product Code HFG

K132744 is an FDA 510(k) premarket notification submitted by Halt Medical, Inc. for the device "ACESSA GUIDANCE SYSTEM". The FDA issued a decision of Substantially Equivalent on May 27, 2014. The device falls under product code HFG (Coagulator, Laparoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Halt Medical, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2014
Date Received
September 3, 2013
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 by Halt Medical, Inc.

  • K132184 — ACESSA GUIDANCE HANDPIECE (April 28, 2014)
  • K121858 — THE ABLATION SYSTEM (November 5, 2012)
  • K094009 — HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI (June 14, 2010)

Other clearances for product code HFG

  • K181124 — Acessa ProVu System (September 28, 2018)
  • 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