FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL
K Number: K983199
·
Decision Dec 14, 1998
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
10
Review Days
91
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Basic Information
- Device Name
- FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL
- K Number
- K983199
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fibra Sonics, Inc.
- Date Received
- September 14, 1998
- Decision Date
- December 14, 1998
- Product Code
- LFL
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | FDA unclassified | Unknown |
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Other Clearances by Fibra Sonics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K993046 | FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 | Nov 22, 1999 | Substantially Equivalent |
| K984199 | EXONIX | Feb 17, 1999 | Substantially Equivalent |
| K984143 | FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM | Feb 16, 1999 | Substantially Equivalent |
| K980930 | FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA | Sep 22, 1998 | Substantially Equivalent |
| K842024 | ULTRASONIC LITHOTRIPTOR 300A | Dec 11, 1984 | Substantially Equivalent |
| K834453 | PHACO FRAGMENTOR GT-1 | Mar 16, 1984 | Substantially Equivalent |
| K813389 | ULTRASONIC FRAGMENTOR | Feb 4, 1982 | Substantially Equivalent |
| K812909 | HYGIENTIST; CYCLOSON I & II; RETROFIT | Dec 14, 1981 | Substantially Equivalent |
| K802381 | LEWICKY ANTERIOR CHAMBER MAINTEN. SYS. | Dec 17, 1980 | Substantially Equivalent |