FDA 510(k)
FDA unclassified
Substantially Equivalent
🇬🇧 United Kingdom
SELECTOR ULTRASONIC SURGICAL ASPIRATOR
K Number: K901974
·
Decision Sep 5, 1990
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
17
Review Days
127
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Basic Information
- Device Name
- SELECTOR ULTRASONIC SURGICAL ASPIRATOR
- K Number
- K901974
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Spembly Medical , Ltd.
- Date Received
- May 1, 1990
- Decision Date
- September 5, 1990
- 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 |
Similar 510(k) Clearances
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CUSA® Clarity Ultrasonic Surgical Aspirator System
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Other Clearances by Spembly Medical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K925129 | SELECTOR | Apr 23, 1993 | Substantially Equivalent |
| K903303 | SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES | Oct 11, 1990 | Substantially Equivalent |
| K882568 | 130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY | Sep 27, 1988 | Substantially Equivalent |
| K882962 | SERIES 40 & SERIES 42 CRYOPROBES (R SERIES) | Aug 8, 1988 | Substantially Equivalent |
| K882963 | SPEMBLY MEDICAL 142 CRYO UNIT | Aug 8, 1988 | Substantially Equivalent |
| K874367 | VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF | Jan 4, 1988 | Substantially Equivalent |
| K840497 | OBSTETRIC PULSAR TWO CHANNEL TENS | Apr 16, 1984 | Substantially Equivalent |
| K832385 | CRYOPROBES MC-1400-CRYOSURG-CONSOLE | Sep 12, 1983 | Substantially Equivalent |
| K832334 | CRYOMEDICS 5000 CRYOSURGICAL CONSOLE | Aug 12, 1983 | Substantially Equivalent |
| K832140 | CRYOMEDICS 5000 CRYOPROBES | Aug 12, 1983 | Substantially Equivalent |