FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TENOSNARE
K Number: K970562
·
Decision May 14, 1997
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
15
Review Days
90
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Basic Information
- Device Name
- TENOSNARE
- K Number
- K970562
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Luxtec Corp.
- Date Received
- February 13, 1997
- Decision Date
- May 14, 1997
- Product Code
- HRX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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Other Clearances by Luxtec Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K973193 | LUXSCOPE | Nov 21, 1997 | Substantially Equivalent |
| K970642 | TENOSCOPE | May 21, 1997 | Substantially Equivalent |
| K950960 | REDDY ILLUMINATOR | Sep 8, 1995 | Substantially Equivalent |
| K895248 | IMS5000 ILLUMINATED LOUPES | Sep 15, 1989 | Substantially Equivalent |
| K890716 | LUXTEC ACO SERIES 4000 LIGHT SOURCE | Apr 26, 1989 | Substantially Equivalent |
| K864387 | LUXTEC FIBEROPTIC CABLES | May 22, 1987 | Substantially Equivalent |
| K864383 | LUXTEC, KILLIAN AND VIENNA NASAL SPECULUMS | Jan 14, 1987 | Substantially Equivalent |
| K864382 | FRAZIER SUCTION TUBE | Jan 14, 1987 | Substantially Equivalent |
| K864385 | LUXTEC LIGHT SOURCES | Jan 13, 1987 | Substantially Equivalent |
| K864865 | SPECULUM, VAGINAL, METAL FIBEROPTIC | Jan 9, 1987 | Substantially Equivalent |