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510(k) K920615

ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT by Anago, Inc. — Product Code CAZ

K920615 is an FDA 510(k) premarket notification submitted by Anago, Inc. for the device "ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT". The FDA issued a decision of Substantially Equivalent (kit, denovo) on March 20, 1993. The device falls under product code CAZ (Anesthesia Conduction Kit), a Class II device regulated under 21 CFR 868.5140. Anago, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
March 20, 1993
Date Received
February 11, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anesthesia Conduction Kit
Device Class
Class II
Regulation Number
868.5140
Review Panel
AN
Submission Type

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Other clearances by Anago, Inc.

  • K925659 — U.C.E.Z. LENS CLEANER KIT (September 17, 1993)
  • K930161 — ANAGO SPINAL ANESTHESIA TRAY (July 6, 1993)
  • K926590 — ANAGO DISPOSABLE INSTANT COLD PACK (May 26, 1993)
  • K926589 — ANAGO WARM PACK (May 26, 1993)
  • K926137 — ANAGO FEM-COOL/FEM-COOL PETITE (May 26, 1993)
  • K915415 — GUARDALL SHIELD (October 15, 1992)
  • K913558 — RELIABLE CONE STYLE FACE MASK (November 7, 1991)
  • K905865 — ANTI-FOR SURGICAL FACE MASK (March 6, 1991)
  • K905749 — SURGICAL FACE MASK (March 4, 1991)
  • K904276 — DISPOSABLE BEARD COVER (November 21, 1990)

Other clearances for product code CAZ

  • K222341 — Arrow 0.2 Micron Flat Filter, GVS (February 13, 2023)
  • K210983 — BD Epilor Syringe (May 19, 2022)
  • K201356 — Plastic LOR Syringe (February 12, 2021)
  • K202699 — E-Cath STIM acc. Tsui (December 29, 2020)
  • K190345 — VPC (May 16, 2019)
  • K161075 — Arrow Epidural Catheter Kit (October 4, 2016)
  • K153652 — ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set (June 21, 2016)
  • K143581 — Arrow Epidural Catheter Kit (June 26, 2015)
  • K122690 — ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE (December 21, 2012)
  • K110053 — CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRIN (September 14, 2012)

FDA data resources