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510(k) K122721

AG GUFFILL by Hospitech Respiration , Ltd. — Product Code BSK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2013
Date Received
September 5, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cuff, Tracheal Tube, Inflatable
Device Class
Class II
Regulation Number
868.5750
Review Panel
AN
Submission Type

Other clearances by Hospitech Respiration , Ltd.

  • K221477 — AG100s (December 29, 2022)
  • K180991 — AG 100s (October 12, 2018)
  • K150157 — AnapnoGuard 100 Respiratory Guard System (February 16, 2016)
  • K131099 — AG MASS (May 13, 2013)
  • K093126 — ANAPNOGUARD ENDOTRACHEAL TUBE (March 2, 2010)

Other clearances for product code BSK

  • K243562 — CuffGuard (August 12, 2025)
  • K242642 — CuffTrek (March 7, 2025)
  • K220854 — TrachCuff Cuff Controller (April 14, 2023)
  • K221477 — AG100s (December 29, 2022)
  • K202874 — Puritan Bennett Cuff Pressure Manager (January 9, 2021)
  • K192611 — Cuffix (August 13, 2020)
  • K191858 — Pylant Monitor (February 24, 2020)
  • K182548 — Accucuff Cuff Pressure Indicator (January 25, 2019)
  • K180991 — AG 100s (October 12, 2018)
  • K173914 — VORTRAN Cuff Inflator (VCI) (May 25, 2018)