Silverstein Microwick
FDA 510(k) K991670 · Micromedics, Inc.
510(k) numberK991670
Submission
- Device name
- Silverstein Microwick
- Applicant
- Micromedics, Inc.
Eagan, MN, US - Received
- May 17, 1999
- Decision date
- August 26, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ETD – Tube, Tympanostomy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3880
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
Other 510(k)s with product code ETD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252436 | Tula Tympanostomy Tube Delivery DeviceETD · Traditional | Tusker Medical, Inc. | 04/23/2026SE |
| K250256 | Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube…ETD · Traditional | Aventamed Dac | 04/28/2025SE |
| K232702 | Solo+ Tympanostomy Tube Device (TTD)ETD · Traditional | Aventamed Dac | 05/20/2024SE |
| K233658 | Biowy Tym Tube (TT)ETD · Traditional | Biowy Corporation | 02/16/2024SE |
| K232059 | Tympanostomy TubesETD · Traditional | Grace Medical, Inc. | 11/24/2023SE |
| K221254 | Hummingbird Tympanostomy Tube SystemETD · Traditional | Preceptis Medical, Inc. | 07/27/2022SE |
| K200952 | Hummingbird Tympanostomy Tube SystemETD · Traditional | Preceptis Medical, Inc. | 06/05/2020SE |
| K171239 | TULA Tube Delivery SystemETD · Special | Tusker Medical | 06/28/2017SE |
| K151830 | Hummingbird Tympanostomy TubeETD · Traditional | Preceptis Medical | 09/21/2015SE |
| K151067 | Ventilation (Tympanostomy) TubesETD · Traditional | Medtronic Xomed, Inc. | 07/22/2015SE |
More from Medtronic Xomed, Inc.
| 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 Silverstein Microwick cleared by the FDA?
Silverstein Microwick (K991670) received a 510(k) decision of Substantially Equivalent on August 26, 1999, 101 days after the submission was received.
What is the product code of K991670?
The FDA product code is ETD – Tube, Tympanostomy, a Class II (moderate risk) device regulated under 21 CFR 874.3880.