FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POREX(TM) EYE SPHERE IMPLANT
K Number: K863943
·
Decision Feb 27, 1987
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
38
Applicant Total
15
Review Days
140
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Basic Information
- Device Name
- POREX(TM) EYE SPHERE IMPLANT
- K Number
- K863943
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.3320
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Porex Medical
- Date Received
- October 10, 1986
- Decision Date
- February 27, 1987
- Product Code
- HPZ
- 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 |
|---|---|---|---|
| HPZ | Implant, Eye Sphere | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HPZ), ordered by most recent decision date.
EZYPOR
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DURETTE OCULAR IMPLANT
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BIOCERAMIC ORBITAL IMPLANT, ORBTEX
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SILICONE SPHERES
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ORBITAL RECONSTRUCTIVE IMPLANT II
FDA 510(k)
FDA Class 2
·Ophthalmic
EYE SPHERES
FDA 510(k)
FDA Class 2
·Ophthalmic
Other Clearances by Porex Medical
| K Number | Device Name | ||
|---|---|---|---|
| K872791 | POREX NERVE LOCATOR | Oct 20, 1987 | Substantially Equivalent |
| K873044 | POREX OTOLOGY INSTRUMENTS | Sep 4, 1987 | Substantially Equivalent |
| K872947 | POREX QUALITY PLASTIC SURGERY INSTRUMENTS | Aug 21, 1987 | Substantially Equivalent |
| K863946 | POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT | Feb 27, 1987 | Substantially Equivalent |
| K870154 | POREX(TM) TISSUE EXPANDER | Feb 24, 1987 | Substantially Equivalent |
| K870182 | POREX(TM) MALAR IMPLANT | Feb 24, 1987 | Substantially Equivalent |
| K870257 | POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T. | Feb 24, 1987 | Substantially Equivalent |
| K863939 | POREX(TM) EAR PROSTHESIS | Oct 24, 1986 | Substantially Equivalent |
| K863942 | POREX(TM) NOSE PROSTHESIS | Oct 24, 1986 | Substantially Equivalent |
| K863941 | POREX(TM) PROSTHESIS, CHIN, INTERNAL | Oct 24, 1986 | Substantially Equivalent |