CLEARVIEW UTERINE MANIPULATOR— 510(k) K940681
Substantially EquivalentClinical Innovations, Inc.
FDA 510(k) clearance K940681 for CLEARVIEW UTERINE MANIPULATOR, Substantially Equivalent on 1994-07-26. Applicant: Clinical Innovations, Inc.. Device class: 2.
Clearance details
- Applicant
- Clinical Innovations, Inc.
- Product code
- Code LKF
- Device class
- Class 2
- Regulation
- 21 CFR 884.4530
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Murray, UT, US
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- K974563 — COLPO CUP CVC-2000
Adverse events under product code LKF
product code LKF- Malfunction
- 643
- Other
- 2
- Total
- 645
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.