FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010
K Number: K011115
·
Decision May 2, 2001
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
13
Applicant Total
14
Review Days
20
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Basic Information
- Device Name
- KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010
- K Number
- K011115
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 886.5700
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Heinz Kurz GmbH Medizintechnik
- Date Received
- April 12, 2001
- Decision Date
- May 2, 2001
- Product Code
- MML
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| MML | Weights, Eyelid, External | FDA class 2 | Ophthalmic |
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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 |
| 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 |
| K000127 | KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10 | Apr 12, 2000 | Substantially Equivalent |