← Product Code [LQC](/submissions/GU/subpart-e%E2%80%94surgical-devices/LQC) · K911477

# LAPAROSCOPIC BASKET FLEXIBLE AND RIGID (K911477)

_United States Endoscopy Group, Inc. · LQC · Aug 14, 1991 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/LQC/K911477

## Device Facts

- **Applicant:** United States Endoscopy Group, Inc.
- **Product Code:** [LQC](/submissions/GU/subpart-e%E2%80%94surgical-devices/LQC.md)
- **Decision Date:** Aug 14, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.4500
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Regulatory 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.

## 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.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/LQC/K911477](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/LQC/K911477)

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