FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POREX(TM) NOSE PROSTHESIS
K Number: K863942
·
Decision Oct 24, 1986
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
41
Applicant Total
15
Review Days
14
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- POREX(TM) NOSE PROSTHESIS
- K Number
- K863942
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3680
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Porex Medical
- Date Received
- October 10, 1986
- Decision Date
- October 24, 1986
- Product Code
- FZE
- 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 |
|---|---|---|---|
| FZE | Prosthesis, Nose, Internal | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FZE), ordered by most recent decision date.
Medicon Epiplating System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Osseointegrated Fixtures
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HANSON MEDICAL FACIAL IMPLANTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MONARCH NASAL IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MONARCH NASAL IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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 |
| K863943 | POREX(TM) EYE SPHERE IMPLANT | Feb 27, 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 |
| K863941 | POREX(TM) PROSTHESIS, CHIN, INTERNAL | Oct 24, 1986 | Substantially Equivalent |