LAPAROLITH— 510(k) K905552
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K905552 for LAPAROLITH, Substantially Equivalent on 1991-12-17. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code LQC
- Device class
- Class 2
- Regulation
- 21 CFR 876.4500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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Adverse events under product code LQC
product code LQC- Death
- 7
- Injury
- 247
- Malfunction
- 956
- Total
- 1,210
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.