GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS— 510(k) K942544

Name: FDA 510(k) clearance K942544
Creator: U.S. Food and Drug Administration
Published: 1994-11-22

Substantially Equivalent

Medi-Globe Corp.

FDA 510(k) clearance K942544 for GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS, Substantially Equivalent on 1994-11-22. Applicant: Medi-Globe Corp.. Device class: 2.

Clearance details

Applicant: Medi-Globe Corp.
Product code: Code LQC
Device class: Class 2
Regulation: 21 CFR 876.4500
Advisory panel: Gastroenterology, Urology
Date received: 1994-05-31
Decision date: 1994-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LQC

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K040447 — TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 10882004-03-12
K011178 — WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR2001-05-04
K964937 — A LITHOTRIPTER-COMPATIBLE BASKET1997-01-24
K943191 — MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR1994-08-29
K905552 — LAPAROLITH1991-12-17

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K061222 — INJECTRA INJECTION NEEDLE2006-07-03
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K011261 — STONE EXTRACTOR BALLOON CATHETER2003-11-17
K010714 — EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 14108302003-01-21
K010549 — BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS)2002-01-18

Adverse events under product code LQC

product code LQC

Death: 7
Injury: 247
Malfunction: 956
Total: 1,210

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.