FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROTEK STAINLESS STEEL PISTON
K Number: K860460
·
Decision Jul 11, 1986
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
73
Applicant Total
24
Review Days
155
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Basic Information
- Device Name
- MICROTEK STAINLESS STEEL PISTON
- K Number
- K860460
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3450
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Microtek Medical, Inc.
- Date Received
- February 6, 1986
- Decision Date
- July 11, 1986
- Product Code
- ETB
- 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 |
|---|---|---|---|
| ETB | Prosthesis, Partial Ossicular Replacement | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ETB), ordered by most recent decision date.
mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735);
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Microtek Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K110358 | VENODYNE V810 | May 5, 2011 | Substantially Equivalent |
| K102971 | FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK | Feb 23, 2011 | Substantially Equivalent |
| K062899 | MICROTEK MEDICAL SURGICAL GOWN/TOGA | Jan 25, 2007 | Substantially Equivalent |
| K060200 | MICROTEK MEDICAL WARMING DRAPE | May 31, 2006 | Substantially Equivalent |
| K050322 | MICROTEK EQUIPMENT DRAPES | May 17, 2005 | Substantially Equivalent |
| K022903 | CHILLBUSTER | Nov 27, 2002 | Substantially Equivalent |
| K020956 | VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA | May 16, 2002 | Substantially Equivalent |
| K011318 | VENODYNE DVT ADVANTAGE PLUS | Oct 25, 2001 | Substantially Equivalent |
| K001802 | VENODYNE DVT ADVANTAGE MODEL 610 | Jan 9, 2001 | Substantially Equivalent |
| K950906 | LESINSKI SURGICAL EAR DRESSING | Jun 22, 1995 | Substantially Equivalent |