← Product Code [PKL](/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL) · K260580

# Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) (K260580)

_Olympus Medical Systems Corp. · PKL · May 21, 2026 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K260580

## Device Facts

- **Applicant:** Olympus Medical Systems Corp.
- **Product Code:** [PKL](/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL.md)
- **Decision Date:** May 21, 2026
- **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/PKL/K260580](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K260580)

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