Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IV
FDA 510(k) K060563 · Pajunk GmbH
510(k) numberK060563
Submission
- Device name
- Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IV
- Applicant
- Pajunk GmbH
Geisingen, DE - Received
- February 8, 2006
- Decision date
- June 2, 2006
- 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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| K040965 | Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford NeedlesBSP · Traditional | 09/07/2004SE |
| K033018 | Stimulong Plus Catheter Set Model, VariousCAZ · Traditional | 05/05/2004SE |
| K033249 | Pajunk Modular Handle InstrumentsGCJ · Traditional | 03/05/2004SE |
| K023218 | Modification to Plexolong SetsBSP · Special | 03/24/2003SE |
Questions and answers
When was Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IV cleared by the FDA?
Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IV (K060563) received a 510(k) decision of Substantially Equivalent on June 2, 2006, 114 days after the submission was received.
What is the product code of K060563?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.