Surgical Sealant Applicator Tip Endoscopic Tip
FDA 510(k) K940371 · Micromedics, Inc.
510(k) numberK940371
Submission
- Device name
- Surgical Sealant Applicator Tip Endoscopic Tip
- Applicant
- Micromedics, Inc.
Eagan, MN, US - Received
- January 6, 1994
- Decision date
- April 6, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KYZ – Syringe, Irrigating (Non Dental)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6960
- Specialty
- General Hospital
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| K982435 | Irrigation Syringe KitKYZ · Traditional | Sub-Q, Inc. | 11/06/1998SE |
| K974288 | Zerowet SplashieldKYZ · Traditional | Zerowet, Inc. | 01/29/1998SE |
| K964833 | Rmi Dual Fluid Irrigating SyringeKYZ · Traditional | Research Medical, Inc. | 02/19/1997SE |
| K960725 | Marpp Pressure Monitoring SystemKYZ · Traditional | Paradigm Medical, Inc. | 07/15/1996SE |
| K960212 | CPR Irrigation TrayKYZ · Traditional | Custom Pack Reliability | 04/01/1996SE |
More from Custom Pack Reliability
| 510(k) | Device | Decision |
|---|---|---|
| K241739 | Endoscopic Applicator, 41 cmGCJ · Special | 07/15/2024SE |
| K123847 | Malleable Tip Endoscopic ApplicatorGCJ · Special | 01/08/2013SE |
| K122526 | 360 Gas Assisted Endoscopic ApplicatorGCJ · Special | 11/16/2012SE |
| K120608 | Endoscopic ApplicatorGCJ · Traditional | 03/15/2012SE |
| K102563 | Single Cannula Extended ApplicatorKYZ · Traditional | 03/15/2011SE |
| K100754 | Graft Delivery System Model SA-6115FMF · Traditional | 06/09/2010SE |
| K073401 | Earpopper, Model EP-2000, EP-2100, EP-3000MJV · Traditional | 03/14/2008SE |
| K061092 | Baxter Duplospray Mis ApplicatorFMF · Traditional | 09/13/2006SE |
| K051157 | Instru-Safe Instrument Protection SystemsKCT · Traditional | 09/01/2005SE |
| K050340 | Micromedics Sphenoid Sinus StentKAM · Traditional | 04/27/2005SE |
Questions and answers
When was Surgical Sealant Applicator Tip Endoscopic Tip cleared by the FDA?
Surgical Sealant Applicator Tip Endoscopic Tip (K940371) received a 510(k) decision of Substantially Equivalent on April 6, 1994, 90 days after the submission was received.
What is the product code of K940371?
The FDA product code is KYZ – Syringe, Irrigating (Non Dental), a Class I (low risk) device regulated under 21 CFR 880.6960.