CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY— 510(k) K964601
Substantially EquivalentValleylab, Inc.
FDA 510(k) clearance K964601 for CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY, Substantially Equivalent on 1997-01-16. Applicant: Valleylab, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Valleylab, Inc.
- Product code
- Code LFL
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boulder, CO, US
Recent devices under product code LFL
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view all- K031011 — LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500
- K010010 — VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR
- K010013 — LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100
- K994428 — E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE
- K983743 — BISURE LAPAROSCOPIC BIPOLAR FORCEPS
Adverse events under product code LFL
product code LFL- Death
- 29
- Injury
- 1,046
- Malfunction
- 21,642
- Total
- 22,717
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.