FORCE GSU TM SYSTEM AND FORCE GSU TM HANDSET— 510(k) K904545
Substantially EquivalentValleylab, Inc.
FDA 510(k) clearance K904545 for FORCE GSU TM SYSTEM AND FORCE GSU TM HANDSET, Substantially Equivalent on 1990-12-28. Applicant: Valleylab, Inc.. Device class: 2.
Clearance details
- Applicant
- Valleylab, Inc.
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boulder, CO, US
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More 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 GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.