FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY
K Number: K964601
·
Decision Jan 16, 1997
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
94
Review Days
59
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Basic Information
- Device Name
- CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY
- K Number
- K964601
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Valleylab, Inc.
- Date Received
- November 18, 1996
- Decision Date
- January 16, 1997
- 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 Valleylab, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K031011 | LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500 | May 29, 2003 | Substantially Equivalent |
| K010010 | VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR | Apr 2, 2001 | Substantially Equivalent |
| K010013 | LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100 | Mar 26, 2001 | Substantially Equivalent |
| K994428 | E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE | Mar 7, 2000 | Substantially Equivalent |
| K983743 | BISURE LAPAROSCOPIC BIPOLAR FORCEPS | Jan 21, 1999 | Substantially Equivalent |
| K981916 | LIGASURE VESSEL SEALING SYSTEM | Aug 28, 1998 | Substantially Equivalent |
| K981262 | CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM | Jul 6, 1998 | Substantially Equivalent |
| K980915 | VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM | Jun 29, 1998 | Substantially Equivalent |
| K970140 | E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH | Mar 28, 1997 | Substantially Equivalent |
| K964636 | FORCE ARGON II ARGON ENHANCED ELECTROSURGICAL SYSTEM | Mar 11, 1997 | Substantially Equivalent |