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510(k) K083428

F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY by Fiab Spa — Product Code HQP

K083428 is an FDA 510(k) premarket notification submitted by Fiab Spa for the device "F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY". The FDA issued a decision of Substantially Equivalent on September 1, 2009. The device falls under product code HQP (Unit, Cautery, Thermal, Battery-Powered), a Class II device regulated under 21 CFR 886.4115. Fiab Spa has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2009
Date Received
November 19, 2008
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 Fiab Spa

  • K192210 — ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System (October 10, 2019)
  • K180047 — ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System (November 8, 2018)
  • K123361 — ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM (February 27, 2013)
  • K103783 — EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDI (June 16, 2011)
  • K100333 — FIAB SPA, MODELS F7244, F7233, F7234, F7277 (June 21, 2010)
  • K091163 — PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSA (July 22, 2009)

Other clearances for product code HQP

  • K121441 — CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FIN (July 20, 2012)
  • 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)
  • K945761 — LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TIP (April 10, 1995)
  • K945763 — LOW TEMPERATURE CAUTERY ELONGATED FINE TIP (February 7, 1995)
  • K945762 — LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE (February 7, 1995)

FDA data resources