FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
SUTURE CORD
K Number: K953128
·
Decision Feb 9, 1996
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
16
Applicant Total
12
Review Days
218
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Basic Information
- Device Name
- SUTURE CORD
- K Number
- K953128
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5000
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Phoenix Biomedical Corp.
- Date Received
- July 6, 1995
- Decision Date
- February 9, 1996
- Product Code
- GAS
- 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 |
|---|---|---|---|
| GAS | Suture, Nonabsorbable, Synthetic, Polyester | FDA class 2 | General, Plastic Surgery |
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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 |
| K962144 | PHOENIX ETE TISSUE EXTENSION SYSTEM | Jan 14, 1997 | Substantially Equivalent |