← Product Code [FFL](/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL) · K863081

# 4-WIRE (CARSON) STONE EXTRACTOR (K863081)

_Cook Urological, Inc. · FFL · Oct 24, 1986 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K863081

## Device Facts

- **Applicant:** Cook Urological, Inc.
- **Product Code:** [FFL](/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL.md)
- **Decision Date:** Oct 24, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.4680
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Regulatory Identification

A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K863081](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K863081)

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