← Product Code [FDI](/submissions/GU/subpart-e%E2%80%94surgical-devices/FDI) · K930022

# SPHINCTEROTOME (K930022)

_Boston Scientific Corp · FDI · Apr 27, 1993 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FDI/K930022

## Device Facts

- **Applicant:** Boston Scientific Corp
- **Product Code:** [FDI](/submissions/GU/subpart-e%E2%80%94surgical-devices/FDI.md)
- **Decision Date:** Apr 27, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.4300
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Regulatory Identification

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FDI/K930022](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FDI/K930022)

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