FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
CUSA SYSTEM 200 MACRO-DISSECTOR
K Number: K864983
·
Decision Jun 23, 1987
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
54
Review Days
183
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Basic Information
- Device Name
- CUSA SYSTEM 200 MACRO-DISSECTOR
- K Number
- K864983
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Cooper Lasersonics, Inc.
- Date Received
- December 22, 1986
- Decision Date
- June 23, 1987
- 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
Other 510(k) clearances with the same product code (LFL), ordered by most recent decision date.
CUSA® Clarity Ultrasonic Surgical Aspirator System
FDA 510(k)
FDA Unclassified
·Unknown
SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile Ultrasonic Surgery Advanced Dissector (SASD45)
FDA 510(k)
FDA Unclassified
·Unknown
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
FDA 510(k)
FDA Unclassified
·Unknown
Tenex 2nd Generation System
FDA 510(k)
FDA Unclassified
·Unknown
CUSA® Clarity Ultrasonic Surgical Aspirator System
FDA 510(k)
FDA Unclassified
·Unknown
Ultrasonic Surgical System
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Cooper Lasersonics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880429 | ILLUMINA 55 CO2 LASER SYSTEM | Apr 18, 1988 | Substantially Equivalent |
| K880427 | ILLUMINA 40 CO2 LASER SYSTEM | Apr 18, 1988 | Substantially Equivalent |
| K880807 | ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SU | Apr 18, 1988 | Substantially Equivalent |
| K880428 | ILLUMINA 25 CO2 LASER SYSTEM | Apr 18, 1988 | Substantially Equivalent |
| K880808 | ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU | Apr 18, 1988 | Substantially Equivalent |
| K880809 | ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU | Apr 18, 1988 | Substantially Equivalent |
| K880171 | MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL | Apr 11, 1988 | Substantially Equivalent |
| K880170 | MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS | Mar 24, 1988 | Substantially Equivalent |
| K880173 | MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION | Mar 24, 1988 | Substantially Equivalent |
| K880172 | MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA. | Mar 11, 1988 | Substantially Equivalent |