Various Anesthetic Kits or Trays

FDA 510(k) K924707 · Specialty Medical Products Co.

Unknown

510(k) numberK924707

Submission

Device name
Various Anesthetic Kits or Trays
Applicant
Specialty Medical Products Co.
Great Neck, NY, US
Received
September 18, 1992
Decision date
June 17, 1993
Decision
Unknown (SEKD)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
CAZ – Anesthesia Conduction Kit
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5140
Specialty
Anesthesiology

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.

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K222341Arrow 0.2 Micron Flat Filter, GVSCAZ · Traditional Arrow International, LLC02/13/2023SE
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K201356Plastic LOR SyringeCAZ · Traditional Jiangsu Caina Medical Co.,Ltd02/12/2021SE
K202699E-Cath STIM acc. TsuiCAZ · Special PAJUNK GmbH Medizintechnologie12/29/2020SE
K190345VPCCAZ · Traditional PAJUNK GmbH Medizintechnologie05/16/2019SE
K161075Arrow Epidural Catheter KitCAZ · Traditional Teleflexmedical, Inc.10/04/2016SE
K153652ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/SetCAZ · Traditional Teleflex, Inc.06/21/2016SE
K143581Arrow Epidural Catheter KitCAZ · Traditional Teleflexmedical, Inc.06/26/2015SE
K122690Ultraquik Peripheral Nerve Block NeedleCAZ · Traditional Arrow International, Inc.12/21/2012SE
K110053Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe KitCAZ · Traditional Smiths Medical Asd, Inc.09/14/2012SE

More from Smiths Medical Asd, Inc.

510(k)DeviceDecision
K922533IV Start Kit Custom SMP # A-ZLRS · Traditional 03/23/1993SEKD
K922845Basic Dressing Change Tray SMP 102AFRG · Traditional 12/29/1992SEKD
K874596Perforated Soaking TubeGBQ · Traditional 12/02/1987SE

Questions and answers

When was Various Anesthetic Kits or Trays cleared by the FDA?

Various Anesthetic Kits or Trays (K924707) received a 510(k) decision of Unknown on June 17, 1993, 272 days after the submission was received.

What is the product code of K924707?

The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.