FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SILVERSTEIN MICROWICK
K Number: K991670
·
Decision Aug 26, 1999
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
115
Applicant Total
29
Review Days
101
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Basic Information
- Device Name
- SILVERSTEIN MICROWICK
- K Number
- K991670
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3880
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Micromedics, Inc.
- Date Received
- May 17, 1999
- Decision Date
- August 26, 1999
- Product Code
- ETD
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ETD | Tube, Tympanostomy | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ETD), ordered by most recent decision date.
Tula Tympanostomy Tube Delivery Device
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Solo+ Tympanostomy Tube Device (TTD)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Biowy Tym Tube (TT)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Tympanostomy Tubes
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Hummingbird Tympanostomy Tube System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Micromedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K241739 | Endoscopic Applicator, 41 cm | Jul 15, 2024 | Substantially Equivalent |
| K123847 | MALLEABLE TIP ENDOSCOPIC APPLICATOR | Jan 8, 2013 | Substantially Equivalent |
| K122526 | 360 GAS ASSISTED ENDOSCOPIC APPLICATOR | Nov 16, 2012 | Substantially Equivalent |
| K120608 | ENDOSCOPIC APPLICATOR | Mar 15, 2012 | Substantially Equivalent |
| K102563 | SINGLE CANNULA EXTENDED APPLICATOR | Mar 15, 2011 | Substantially Equivalent |
| K100754 | GRAFT DELIVERY SYSTEM MODEL SA-6115 | Jun 9, 2010 | Substantially Equivalent |
| K073401 | EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 | Mar 14, 2008 | Substantially Equivalent |
| K061092 | BAXTER DUPLOSPRAY MIS APPLICATOR | Sep 13, 2006 | Substantially Equivalent |
| K051157 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS | Sep 1, 2005 | Substantially Equivalent |
| K050340 | MICROMEDICS SPHENOID SINUS STENT | Apr 27, 2005 | Substantially Equivalent |