FDA product code LQC: Lithotriptor, Biliary Mechanical
LQC is the FDA product code for lithotriptor, biliary mechanical. It is a Class II device, regulated under 21 CFR 876.4500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 11 510(k) submissions under LQC, from 8 different applicants. The average 510(k) review took 121 days (median 72). FDA has posted 7 recalls for LQC devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Lithotriptor, Biliary Mechanical |
| Device class | Class II |
| Regulation | 21 CFR 876.4500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LQC clearance
Top LQC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Scientific Corp | 3 | 2004-03-12 |
| Wilson-Cook Medical, Inc. | 2 | 2001-05-04 |
| Medi-Globe Corp. | 1 | 1994-11-22 |
| Baxter Healthcare Corp | 1 | 1991-12-17 |
| Northgate Technologies, Inc. | 1 | 1991-10-23 |
3 more applicants have LQC clearances. See the full list in Caduvo.
Most recent LQC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K040447 | Boston Scientific Corp | TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088 | 2004-03-12 | 21 |
| K011178 | Wilson-Cook Medical, Inc. | WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR | 2001-05-04 | 17 |
| K964937 | Boston Scientific Corp | A LITHOTRIPTER-COMPATIBLE BASKET | 1997-01-24 | 45 |
| K942544 | Medi-Globe Corp. | GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS | 1994-11-22 | 175 |
| K943191 | Boston Scientific Corp | MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR | 1994-08-29 | 55 |
Recalls for LQC devices
7 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-12-16.
| Year | Recalls |
|---|---|
| 2021 | 2 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code LQC?
LQC is the FDA product code for lithotriptor, biliary mechanical. It is a Class II device, regulated under 21 CFR 876.4500 and reviewed by the Gastroenterology and Urology panel.
What device class is LQC?
Class II, regulation 21 CFR 876.4500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LQC?
Across 11 cleared submissions the average was 121 days from receipt to decision (median 72).
Which companies have the most LQC clearances?
Boston Scientific Corp (3); Wilson-Cook Medical, Inc. (2); Medi-Globe Corp. (1); Baxter Healthcare Corp (1); Northgate Technologies, Inc. (1).
Have LQC devices been recalled?
Yes: 7 product recalls across 3 recall events; the most recent began 2024-12-16.
Next steps
- Run an FDA pathway report with predicate devices for product code LQC
- Run a recall and safety report across every LQC manufacturer
- Watch product code LQC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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