FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SILICONE SOFT-PAK EPISTAXIS CATHETER
K Number: K832476
·
Decision Nov 3, 1983
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
1
Applicant Total
28
Review Days
100
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Basic Information
- Device Name
- SILICONE SOFT-PAK EPISTAXIS CATHETER
- K Number
- K832476
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4175
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Axiom Medical, Inc.
- Date Received
- July 26, 1983
- Decision Date
- November 3, 1983
- Product Code
- ENW
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| ENW | Catheter, Nasopharyngeal | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ENW), ordered by most recent decision date.
View allOther 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 |
| K905422 | PVC ROUND WOUND DRAINS | Feb 11, 1991 | 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 |