Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart E — Surgical Devices](/submissions/GU/subpart-e%E2%80%94surgical-devices) → [21 CFR 876.4500](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4500) → LQC — Lithotriptor, Biliary Mechanical

# LQC · Lithotriptor, Biliary Mechanical

_Gastroenterology, Urology · 21 CFR 876.4500 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/LQC

## Overview

- **Product Code:** LQC
- **Device Name:** Lithotriptor, Biliary Mechanical
- **Regulation:** [21 CFR 876.4500](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4500)
- **Device Class:** 2
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## Identification

A mechanical lithotriptor is a device with steel jaws that is inserted into the urinary bladder through the urethra to grasp and crush bladder stones.

## Classification Rationale

Class II (special controls). The device, when it is a biliary mechanical lithotripter, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

## Special Controls

*Classification.* Class II (special controls). The device, when it is a biliary mechanical lithotripter, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

## Recent Cleared Devices (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K040447](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/LQC/K040447.md) | TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088 | Boston Scientific Corp | Mar 12, 2004 | SESE |
| [K011178](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/LQC/K011178.md) | WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR | Wilson-Cook Medical, Inc. | May 4, 2001 | SESE |
| [K964937](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/LQC/K964937.md) | A LITHOTRIPTER-COMPATIBLE BASKET | Boston Scientific Corp | Jan 24, 1997 | SESE |
| [K942544](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/LQC/K942544.md) | GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS | Medi-Globe Corp. | Nov 22, 1994 | SESE |
| [K943191](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/LQC/K943191.md) | MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR | Boston Scientific Corp | Aug 29, 1994 | SESE |
| [K905552](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/LQC/K905552.md) | LAPAROLITH | Baxter Healthcare Corp | Dec 17, 1991 | SESE |
| [K911364](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/LQC/K911364.md) | SPOON FORCEPS, 11MM | Northgate Technologies, Inc. | Oct 23, 1991 | SESE |
| [K911477](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/LQC/K911477.md) | LAPAROSCOPIC BASKET FLEXIBLE AND RIGID | United States Endoscopy Group, Inc. | Aug 14, 1991 | SESE |
| [K903529](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/LQC/K903529.md) | BML SERIES | Olympus Corp. | Jan 23, 1991 | SESE |
| [K902170](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/LQC/K902170.md) | SOEHENDRA LITHOTRIPSY SET | Wilson-Cook Medical, Inc. | Jul 25, 1990 | SESE |
| [K860863](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/LQC/K860863.md) | ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER | George Percy Mcgown | May 15, 1986 | SESE |

## Top Applicants

- Boston Scientific Corp — 3 clearances
- Wilson-Cook Medical, Inc. — 2 clearances
- United States Endoscopy Group, Inc. — 1 clearance
- Olympus Corp. — 1 clearance
- Northgate Technologies, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/LQC](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/LQC)

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