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510(k) K971621

RESISTICK SOLID LAPAROSCOPIC ELECTRODES by Aaron Medical Industries — Product Code KNF

K971621 is an FDA 510(k) premarket notification submitted by Aaron Medical Industries for the device "RESISTICK SOLID LAPAROSCOPIC ELECTRODES". The FDA issued a decision of Substantially Equivalent on June 20, 1997. The device falls under product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Aaron Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1997
Date Received
May 1, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Device Class
Class II
Regulation Number
884.4160
Review Panel
OB
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 KNF

  • K250705 — Sonata Transcervical Fibroid Ablation System 2.2 (April 2, 2025)
  • K240503 — Sonata Transcervical Fibroid Ablation System 2.2 (July 17, 2024)
  • K233848 — Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) (December 21, 2023)
  • K222304 — Sonata Transcervical Fibroid Ablation System 2.2 (November 8, 2022)
  • K211535 — Sonata Transcervical Fibroid Ablation System 2.2 (June 17, 2021)
  • K193516 — Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 (May 4, 2020)
  • K173703 — Sonata Sonography-Guided Transcervical Fibroid Ablation System (August 15, 2018)
  • K132135 — LINA GOLD LOOP HC (January 31, 2014)
  • K121343 — MODULAP LOOP (June 14, 2013)
  • K103726 — JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS (February 8, 2012)

FDA data resources