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510(k) K120532

GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM by Getinge Sourcing, LLC — Product Code PEC

K120532 is an FDA 510(k) premarket notification submitted by Getinge Sourcing, LLC for the device "GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM". The FDA issued a decision of Substantially Equivalent on May 2, 2013. The device falls under product code PEC (Sterilizer Automated Loading System), a Class II device regulated under 21 CFR 880.6880. Getinge Sourcing, LLC has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2013
Date Received
February 22, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer Automated Loading System
Device Class
Class II
Regulation Number
880.6880
Review Panel
HO
Submission Type

Provides automated loading and unloading of instruments requiring sterilization for increasing hospital work flow efficiencies. The system consists of a user interface, loading conveyor, load transport shuttles, unloading conveyor to be used as an accessory to a sterilizer.

Other clearances by Getinge Sourcing, LLC

  • K153713 — Getinge Series Warming Cabinet (June 7, 2016)
  • K122625 — GETINGE 800HC- SERIES STEAM STERILIZER (May 22, 2013)
  • K122071 — GETINGE 400HC-E / SERIES STEAM STERILIZER (March 12, 2013)
  • K120441 — GETINGE 700HC-E SERIES STEAM STERILIZER (May 31, 2012)
  • K103504 — GETINGE 400HC/500HC SERIES STEAM STERILIZER (March 16, 2011)
  • K070657 — GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER (April 5, 2007)

FDA data resources