CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM— 510(k) K981262
Substantially EquivalentValleylab, Inc.
FDA 510(k) clearance K981262 for CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM, Substantially Equivalent on 1998-07-06. 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
view allMore clearances from Valleylab, Inc.
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 →
Recalls naming K981262
K-number listed on FDA's recall record- Z-1522-2014 — Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wrench is used to properly secure the CUSA tip to the CUSA handpiece in the sterile field.
- Z-0920-2013 — Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K981262.
Data sourced from openFDA. This site is unofficial and independent of the FDA.