← Product Code [FHN](/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN) · K801352

# HEMORRHOIDAL LIGATION INSTR. SYSTEM (K801352)

_Depuy, Inc. · FHN · Jul 8, 1980 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN/K801352

## Device Facts

- **Applicant:** Depuy, Inc.
- **Product Code:** [FHN](/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN.md)
- **Decision Date:** Jul 8, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.4400
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Regulatory Identification

A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.

## Special Controls

*Classification.* Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device 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/FHN/K801352](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN/K801352)

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