FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PHOENIX ETE TISSUE EXTENSION SYSTEM
K Number: K962144
·
Decision Jan 14, 1997
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
5
Applicant Total
12
Review Days
225
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
- PHOENIX ETE TISSUE EXTENSION SYSTEM
- K Number
- K962144
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4320
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Phoenix Biomedical Corp.
- Date Received
- June 3, 1996
- Decision Date
- January 14, 1997
- Product Code
- MKY
- 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 |
|---|---|---|---|
| MKY | System, Skin Closure | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MKY), ordered by most recent decision date.
WISEBANDS SKIN CLOSURE DEVICE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PROXIDERM, MODELS TN 460, TN 90 460, BK 460
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PROXIDERM (D-460,D 90 460,D 180,460, PS 460)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PROXIDERM (TENTATIVE)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Phoenix Biomedical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K030468 | ACURA ELITE GRAVITY COMPENSATING RESERVOIR | Oct 15, 2003 | Substantially Equivalent |
| K024101 | PHOENIX UNIVERSAL SHUNT SYSTEM | Jan 27, 2003 | Substantially Equivalent |
| K024040 | ACCURA ELITE SHUNT SYSTEM | Jan 27, 2003 | Substantially Equivalent |
| K021644 | PERF (OMMAYA STYLE) RESERVOIRS | Aug 6, 2002 | Substantially Equivalent |
| K002476 | LUMBOPERITONEAL SHUNT SYSTEM | Nov 9, 2000 | Substantially Equivalent |
| K000514 | RUMBAR DRAINAGE SYSTEM | May 10, 2000 | Substantially Equivalent |
| K991429 | DIAMOND II VALVE | May 19, 1999 | Substantially Equivalent |
| K990256 | CRX WORLD SHUNT | Apr 1, 1999 | Substantially Equivalent |
| K974096 | CRX DIAMOND VALVE | Dec 8, 1998 | Substantially Equivalent |
| K960435 | PHOENIX CRX VALVE | Aug 27, 1996 | Substantially Equivalent |