FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO LASER-SHIELD II
K Number: K993582
·
Decision Jan 20, 2000
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
82
Review Days
90
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Basic Information
- Device Name
- MODIFICATION TO LASER-SHIELD II
- K Number
- K993582
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Xomed, Inc.
- Date Received
- October 22, 1999
- Decision Date
- January 20, 2000
- Product Code
- BTR
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | FDA class 2 | Anesthesiology |
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Other Clearances by Xomed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002395 | MODEL 30 CLASSIC PNEUMATONOMETER | Dec 11, 2000 | Substantially Equivalent |
| K002987 | REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE | Dec 4, 2000 | Substantially Equivalent |
| K002828 | XPS NITRO SYSTEM | Oct 17, 2000 | Substantially Equivalent |
| K002897 | TITANIUM MIDDLE EAR PROSTHESES | Oct 11, 2000 | Substantially Equivalent |
| K993653 | MICRO-FRANCE TROCARS AND ACCESSORIES | Jun 9, 2000 | Substantially Equivalent |
| K001148 | MEROGEL OTOLOGIC PACK | Jun 3, 2000 | Substantially Equivalent |
| K994262 | FRONTAL SINUS TREPHINATION CANNULA | Feb 8, 2000 | Substantially Equivalent |
| K992855 | XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT | Jan 21, 2000 | Substantially Equivalent |
| K993655 | MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS | Dec 21, 1999 | Substantially Equivalent |
| K993112 | XOMED ENT RF SYSTEM | Dec 9, 1999 | Substantially Equivalent |