FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PVC ROUND WOUND DRAINS
K Number: K905422
·
Decision Feb 11, 1991
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
76
Applicant Total
28
Review Days
69
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Basic Information
- Device Name
- PVC ROUND WOUND DRAINS
- K Number
- K905422
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Axiom Medical, Inc.
- Date Received
- December 4, 1990
- Decision Date
- February 11, 1991
- Product Code
- GBX
- 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 |
|---|---|---|---|
| GBX | Catheter, Irrigation | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Axiom Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K993592 | AXIOM MULTIPURPOSE WOUND DRAIN | May 17, 2000 | Substantially Equivalent |
| K971851 | INTERPLEURAL ANESTHESIA CATHETER | Jan 22, 1998 | Substantially Equivalent |
| K965146 | FLAT CLOSED WOUND DRAIN WITH TROCAR | Mar 10, 1997 | Substantially Equivalent |
| K934895 | GLASSMAN SILICONE CATHETER | Oct 13, 1994 | Substantially Equivalent |
| K922760 | ATRAUM WOUND DRESSING--MODIFICATION | Oct 30, 1992 | Substantially Equivalent |
| K904218 | SUCTION SYSTEM | Oct 31, 1990 | Substantially Equivalent |
| K904133 | DISPOSABLE FLUID COLLECTION BAG | Oct 11, 1990 | Substantially Equivalent |
| K863247 | AXIOM TROCAR THORACIC CATHETER | Aug 29, 1986 | Substantially Equivalent |
| K861306 | SUCTION SYSTEM | Jun 9, 1986 | Substantially Equivalent |
| K852614 | ATRAUM WOUND DRESSING | Aug 30, 1985 | Substantially Equivalent |