FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN
K Number: K972585
·
Decision Aug 4, 1997
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
38
Applicant Total
14
Review Days
25
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Basic Information
- Device Name
- AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN
- K Number
- K972585
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3495
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Heinz Kurz GmbH Medizintechnik
- Date Received
- July 10, 1997
- Decision Date
- August 4, 1997
- Product Code
- ETA
- 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 |
|---|---|---|---|
| ETA | Replacement, Ossicular Prosthesis, Total | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ETA), ordered by most recent decision date.
mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50
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KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM
FDA 510(k)
FDA Class 2
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Other Clearances by Heinz Kurz GmbH Medizintechnik
| K Number | Device Name | ||
|---|---|---|---|
| K130512 | NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS | Dec 2, 2013 | Substantially Equivalent |
| K112616 | NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS | Feb 8, 2013 | Substantially Equivalent |
| K071150 | TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE | Dec 12, 2007 | Substantially Equivalent |
| K042503 | KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM | Oct 1, 2004 | Substantially Equivalent |
| K033796 | KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS | Jan 30, 2004 | Substantially Equivalent |
| K021479 | CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 | May 21, 2002 | Substantially Equivalent |
| K013573 | CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257 | Nov 9, 2001 | Substantially Equivalent |
| K011115 | KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010 | May 2, 2001 | Substantially Equivalent |
| K002221 | KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170 | Aug 9, 2000 | Substantially Equivalent |
| K001123 | KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111 | Apr 21, 2000 | Substantially Equivalent |