ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER— 510(k) K860863
Substantially EquivalentGeorge Percy Mcgown
FDA 510(k) clearance K860863 for ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER, Substantially Equivalent on 1986-05-15. Applicant: George Percy Mcgown. Device class: 2.
Clearance details
- Applicant
- George Percy Mcgown
- 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
- Pembroke Pines, FL, US
Recent devices under product code LQC
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- K011178 — WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR
- K964937 — A LITHOTRIPTER-COMPATIBLE BASKET
- K942544 — GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS
- K943191 — MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR
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.