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510(k) K945761

LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TIP by Aaron Medical Industries — Product Code HQP

K945761 is an FDA 510(k) premarket notification submitted by Aaron Medical Industries for the device "LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TIP". The FDA issued a decision of Substantially Equivalent on April 10, 1995. The device falls under product code HQP (Unit, Cautery, Thermal, Battery-Powered), a Class II device regulated under 21 CFR 886.4115. Aaron Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1995
Date Received
November 9, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cautery, Thermal, Battery-Powered
Device Class
Class II
Regulation Number
886.4115
Review Panel
OP
Submission Type

Other clearances by Aaron Medical Industries

  • K062337 — MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (October 5, 2006)
  • K061307 — BOVIE INAFLASH SUTURE REMOVER HANDLE,CHARGER,HANDLE AND CHARGER,KIT,BATTERY PACK (July 18, 2006)
  • K060117 — BOVIE BUTTON REMOTE HAND SWITCH (February 22, 2006)
  • K022856 — BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATOR (February 10, 2003)
  • K021817 — AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL (July 11, 2002)
  • K020579 — AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03 (May 13, 2002)
  • K014201 — AARON REUSABLE ELECTROSURGICAL ELECTRODE (February 25, 2002)
  • K001955 — AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250 (December 22, 2000)
  • K001382 — AARON 2100 HIGH FREQUENCY ELECTROSURGICAL GENERATOR (June 27, 2000)
  • K000961 — AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE (April 19, 2000)

Other clearances for product code HQP

  • K121441 — CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FIN (July 20, 2012)
  • K083428 — F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTER (September 1, 2009)
  • K062659 — KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES (March 9, 2007)
  • K023506 — SURGICAL MEDICAL DEVICE CAUTERY (January 13, 2004)
  • K002547 — STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR (October 20, 2000)
  • K994019 — CAUTERY GRASPER/DISSECTOR (January 20, 2000)
  • K990728 — THERMAL CAUTERY DEVICE, FORCEPS (June 3, 1999)
  • K952784 — OXBORO-MEDICAL CAUTERY TIP CLEANER (July 13, 1995)
  • K945763 — LOW TEMPERATURE CAUTERY ELONGATED FINE TIP (February 7, 1995)
  • K945762 — LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE (February 7, 1995)

FDA data resources