FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE SILICONE EPISTAXIS CATHETER
K Number: K973656
·
Decision Nov 18, 1997
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
46
Applicant Total
12
Review Days
54
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Basic Information
- Device Name
- DISPOSABLE SILICONE EPISTAXIS CATHETER
- K Number
- K973656
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4100
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Specialty Surgical Products, Inc.
- Date Received
- September 25, 1997
- Decision Date
- November 18, 1997
- Product Code
- EMX
- 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 |
|---|---|---|---|
| EMX | Balloon, Epistaxis | FDA class 1 | Ear, Nose, Throat |
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Other Clearances by Specialty Surgical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K140383 | ALLOX2 TISSUE EXPANDERS | Oct 28, 2014 | Substantially Equivalent |
| K984106 | MAMMARY SIZER, MAMMARY PROTHESIS SIZER | Feb 12, 1999 | Substantially Equivalent |
| K983015 | VIRILIS PENILE PROSTHESIS | Feb 5, 1999 | Substantially Equivalent |
| K982258 | MAMMARY SIZER | Sep 8, 1998 | Substantially Equivalent |
| K982065 | STERILE SILICONE EXTERNAL WOUND COVER | Aug 12, 1998 | Substantially Equivalent |
| K982067 | MAGNETIC PORT SILICONE TISSUE EXPANDER | Jul 13, 1998 | Substantially Equivalent |
| K974653 | SILICONE ELASTOMER SHEETING | Mar 13, 1998 | Substantially Equivalent |
| K974654 | SILICONE BLOCKS | Feb 24, 1998 | Substantially Equivalent |
| K974209 | SILICONE TISSUE/INFLATABLE TISSUE EXPANDER | Feb 6, 1998 | Substantially Equivalent |
| K973082 | VENTRAL WALL DEFECT REDUCTION SILO | Nov 4, 1997 | Substantially Equivalent |