Yankauer Suction Instru./Laytex Gloves/Suct. Cath.
FDA 510(k) K881429 · Medical Repackers Co.
510(k) numberK881429
Submission
- Device name
- Yankauer Suction Instru./Laytex Gloves/Suct. Cath.
- Applicant
- Medical Repackers Co.
Fort Payne, AL, US - Received
- March 29, 1988
- Decision date
- April 25, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K161075 | Arrow Epidural Catheter KitCAZ · Traditional | Teleflexmedical, Inc. | 10/04/2016SE |
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| K143581 | Arrow Epidural Catheter KitCAZ · Traditional | Teleflexmedical, Inc. | 06/26/2015SE |
| K122690 | Ultraquik Peripheral Nerve Block NeedleCAZ · Traditional | Arrow International, Inc. | 12/21/2012SE |
| K110053 | Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe KitCAZ · Traditional | Smiths Medical Asd, Inc. | 09/14/2012SE |
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Questions and answers
When was Yankauer Suction Instru./Laytex Gloves/Suct. Cath. cleared by the FDA?
Yankauer Suction Instru./Laytex Gloves/Suct. Cath. (K881429) received a 510(k) decision of Substantially Equivalent on April 25, 1988, 27 days after the submission was received.
What is the product code of K881429?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.