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510(k) K991424

INSULSCAN INSULATION TESTING SYSTEM by Medicor Corp. — Product Code HFG

K991424 is an FDA 510(k) premarket notification submitted by Medicor Corp. for the device "INSULSCAN INSULATION TESTING SYSTEM". The FDA issued a decision of Substantially Equivalent on July 22, 1999. 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
July 22, 1999
Date Received
April 23, 1999
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

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  • 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)
  • 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