Home / 510(k) Clearances / K061307

510(k) K061307

BOVIE INAFLASH SUTURE REMOVER HANDLE,CHARGER,HANDLE AND CHARGER,KIT,BATTERY PACK by Aaron Medical Industries — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2006
Date Received
May 10, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Aaron Medical Industries

  • K062337 — MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (October 5, 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)
  • K984352 — AARON TOP50 REUSABLE ELECTROSURGICAL PENCIL, MODEL #ESPR (March 4, 1999)

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