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) → FGK — Tripsor, Stone, Bladder

# FGK · Tripsor, Stone, Bladder

_Gastroenterology, Urology · 21 CFR 876.4500 · Class 2_

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

## Overview

- **Product Code:** FGK
- **Device Name:** Tripsor, Stone, Bladder
- **Regulation:** [21 CFR 876.4500](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4500)
- **Device Class:** 2
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)
- **3rd-party reviewable:** yes

## 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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K760273](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FGK/K760273.md) | LITHOTRITE | V. Mueller O.V. Baxter Healthcare Corp. | Dec 6, 1976 | SESE |

## Top Applicants

- V. Mueller O.V. Baxter Healthcare Corp. — 1 clearance

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

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