FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XANAR MODEL XSE-300 SMOKE EVACULATER
K Number: K844087
·
Decision Feb 27, 1985
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
74
Applicant Total
12
Review Days
128
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Basic Information
- Device Name
- XANAR MODEL XSE-300 SMOKE EVACULATER
- K Number
- K844087
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5070
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Xanar, Inc.
- Date Received
- October 22, 1984
- Decision Date
- February 27, 1985
- Product Code
- FYD
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FYD | Apparatus, Exhaust, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Xanar, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861688 | XANAR CO2 SURGICAL LASER SYSTEM MODEL XAP-15 | Oct 3, 1986 | Substantially Equivalent |
| K852436 | AMBULASE | Apr 18, 1986 | Substantially Equivalent |
| K860496 | MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARY | Mar 14, 1986 | Substantially Equivalent |
| K853620 | MODEL XA-50 - CO2 SURGICAL LASER | Jan 24, 1986 | Substantially Equivalent |
| K850818 | CO 2 SURGICAL LASER SYSTEM NA-120 | Aug 15, 1985 | Substantially Equivalent |
| K850804 | CO 2 SURGICAL LASER SYSTEM NA-30 | Aug 15, 1985 | Substantially Equivalent |
| K850805 | CO 2 SURGICAL LASER SYSTEM MODEL NA-40 | Aug 15, 1985 | Substantially Equivalent |
| K841860 | CO2 SURGICAL LASER SYSTEM XML-10 | Nov 8, 1984 | Substantially Equivalent |
| K833325 | AMBULASE XAM-15 XANAR SURG. LASER | Jan 26, 1984 | Substantially Equivalent |
| K837224 | UNKNOWN | May 2, 1983 | Substantially Equivalent |