FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE
K Number: K912418
·
Decision Dec 20, 1991
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
18
Applicant Total
29
Review Days
203
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Basic Information
- Device Name
- SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE
- K Number
- K912418
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Micromedics, Inc.
- Date Received
- May 31, 1991
- Decision Date
- December 20, 1991
- Product Code
- KAM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| KAM | Cannula, Sinus | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KAM), ordered by most recent decision date.
RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
RELIEVA STRATUS MICROFLOW SPACER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SINUS SPACER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Micromedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |