Single Cannula Extended Applicator
FDA 510(k) K102563 · Micromedics, Inc.
510(k) numberK102563
Submission
- Device name
- Single Cannula Extended Applicator
- Applicant
- Micromedics, Inc.
St. Paul, MN, US - Received
- September 7, 2010
- Decision date
- March 15, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K122526 | 360 Gas Assisted Endoscopic ApplicatorGCJ · Special | 11/16/2012SE |
| K120608 | Endoscopic ApplicatorGCJ · Traditional | 03/15/2012SE |
| 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 |
| K042834 | Micromedics Fibrijet Air Assisted Endoscopic ApplicatorGCJ · Traditional | 02/11/2005SE |
Questions and answers
When was Single Cannula Extended Applicator cleared by the FDA?
Single Cannula Extended Applicator (K102563) received a 510(k) decision of Substantially Equivalent on March 15, 2011, 189 days after the submission was received.
What is the product code of K102563?
The FDA product code is KYZ – Syringe, Irrigating (Non Dental), a Class I (low risk) device regulated under 21 CFR 880.6960.