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510(k) K100333

FIAB SPA, MODELS F7244, F7233, F7234, F7277 by Fiab Spa — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2010
Date Received
February 5, 2010
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 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)
  • K083428 — F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTER (September 1, 2009)
  • K091163 — PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSA (July 22, 2009)

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