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510(k) K932139

LIGHTED INTUBATION STYLET W/REPLACEABLE SHAFT by Aaron Medical Industries — Product Code FSQ

K932139 is an FDA 510(k) premarket notification submitted by Aaron Medical Industries for the device "LIGHTED INTUBATION STYLET W/REPLACEABLE SHAFT". The FDA issued a decision of Substantially Equivalent on July 30, 1993. The device falls under product code FSQ (Light, Surgical, Instrument), a Class II device regulated under 21 CFR 878.4580. Aaron Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1993
Date Received
May 4, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Instrument
Device Class
Class II
Regulation Number
878.4580
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 FSQ

  • K930686 — MIDMARK SURGICAL LIGHTING SYSTEMS (July 30, 1993)
  • K922409 — ALM ILLUMINATOR SERIES LIGHT SYSTEM (January 12, 1993)
  • K921848 — BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT (October 1, 1992)
  • K803067 — SURG-FLEX 10 LIGHT (February 26, 1981)
  • K810019 — SURG-FLEX 15 SURGICAL LIGHT (January 23, 1981)
  • K810018 — SURG-FLEX 5 SURGICAL LIGHT (January 23, 1981)

FDA data resources