Epidural Anesthesia Kit and Combined Spinal Epidural Anesthesia Kit
FDA 510(k) K962821 · Global Medical Products, Ltd.
510(k) numberK962821
Submission
- Device name
- Epidural Anesthesia Kit and Combined Spinal Epidural Anesthesia Kit
- Applicant
- Global Medical Products, Ltd.
Woodbury, CT, US - Received
- July 19, 1996
- Decision date
- November 13, 1996
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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More from Smiths Medical Asd, Inc.
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|---|---|---|
| K970916 | H.V. Pulse Lavage (L31 Series)FQH · Traditional | 06/20/1997SE |
| K961444 | Global Medical Combined Spinal Epidural Kit (Gma 1827 and Gma 1725)BSP · Traditional | 08/01/1996SE |
| K951448 | Global Medical Products Potts Cournand, Seldinger Style Needle, Single, Winged Single…DRC · Traditional | 03/27/1996SE |
| K951421 | Global Medical Products Chiba, Franseen, Westcott Style, Menghini, Turner, Greene NeedlesFCG · Traditional | 11/16/1995SE |
| K950311 | Global Medical Products Brest Lesion Localization Needle with Stiffened WireGDF · Traditional | 05/26/1995SE |
Questions and answers
When was Epidural Anesthesia Kit and Combined Spinal Epidural Anesthesia Kit cleared by the FDA?
Epidural Anesthesia Kit and Combined Spinal Epidural Anesthesia Kit (K962821) received a 510(k) decision of Unknown on November 13, 1996, 117 days after the submission was received.
What is the product code of K962821?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.