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510(k) K974735

STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE by Aaron Medical Industries — Product Code JOS

K974735 is an FDA 510(k) premarket notification submitted by Aaron Medical Industries for the device "STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE". The FDA issued a decision of Substantially Equivalent on June 24, 1998. The device falls under product code JOS (Electrode, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Aaron Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1998
Date Received
December 18, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrosurgical
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
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 JOS

  • K161600 — Resection Electrodes (September 6, 2016)
  • K050923 — LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTI (May 18, 2005)
  • K012684 — REPROCESSED ELECTROSURGICAL ELECTRODE (January 18, 2002)
  • K011515 — MEDLINE GROUNDING PAD (July 13, 2001)
  • K003403 — ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999 (May 7, 2001)
  • K000333 — STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL, (May 3, 2000)
  • K993885 — ULTRABLATOR ELECTRODE (February 10, 2000)
  • K991830 — CAPSULAR SHRINKAGE ELECTRODE (August 20, 1999)
  • K973554 — VALLEY FORGE BIPOLAR BALL TIP ELECTRODE (December 19, 1997)
  • K971187 — STANDARD & EXTENDED BLADE/NEEDLE/BALL;MODIFIED STANDARD & EXTENDED BLADE/NEEDLE (May 5, 1997)

FDA data resources