Glass Loss of Resistance Syringe
FDA 510(k) K063018 · Busse Hospital Disposables, Inc.
510(k) numberK063018
Submission
- Device name
- Glass Loss of Resistance Syringe
- Applicant
- Busse Hospital Disposables, Inc.
Hauppauge, NY, US - Received
- October 2, 2006
- Decision date
- January 22, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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|---|---|---|
| K141285 | Busse Extension SetFPA · Traditional | 02/19/2015SE |
| K120002 | I-Style Bone Marrow Aspiration Needle with T-HandleKNW · Traditional | 06/26/2012SE |
| K110883 | J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Marrow Acquisition CannulaKNW · Traditional | 06/08/2011SE |
| K093920 | Busse Epidural Catheter KitBSO · Traditional | 08/06/2010SE |
| K093909 | Busse Surgical Drapes IVKKX · Traditional | 05/06/2010SE |
| K092212 | Busse Surgical Drapes IIIKKX · Special | 10/09/2009SE |
| K082297 | Busse Surgical DrapeKKX · Traditional | 12/09/2008SE |
| K073222 | Modification To:Specialty NeedlesBSP · Special | 04/09/2008SE |
| K070465 | Busse Epidural CatheterBSO · Traditional | 07/19/2007SE |
| K061394 | Specialty Needles (Spinal Needle, Pencil Point Spinal Needle, Epidural Needle)BSP · Traditional | 09/06/2006SE |
Questions and answers
When was Glass Loss of Resistance Syringe cleared by the FDA?
Glass Loss of Resistance Syringe (K063018) received a 510(k) decision of Substantially Equivalent on January 22, 2007, 112 days after the submission was received.
What is the product code of K063018?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.