E-Cath STIM acc. Tsui
FDA 510(k) K202699 · PAJUNK GmbH Medizintechnologie
510(k) numberK202699
Submission
- Device name
- E-Cath STIM acc. Tsui
- Applicant
- PAJUNK GmbH Medizintechnologie
Geisingen, DE - Received
- September 16, 2020
- Decision date
- December 29, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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Questions and answers
When was E-Cath STIM acc. Tsui cleared by the FDA?
E-Cath STIM acc. Tsui (K202699) received a 510(k) decision of Substantially Equivalent on December 29, 2020, 104 days after the submission was received.
What is the product code of K202699?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.