Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart E — Surgical Devices](/submissions/GU/subpart-e%E2%80%94surgical-devices) → [21 CFR 876.4400](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4400) → PKL — Hemostatic Metal Clip For The Gi Tract # PKL · Hemostatic Metal Clip For The Gi Tract _Gastroenterology, Urology · 21 CFR 876.4400 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL ## Overview - **Product Code:** PKL - **Device Name:** Hemostatic Metal Clip For The Gi Tract - **Regulation:** [21 CFR 876.4400](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4400) - **Device Class:** 2 - **Review Panel:** [Gastroenterology, Urology](/submissions/GU) - **Implant:** yes - **Life-sustaining:** yes ## 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. ## Classification Rationale 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. ## 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. ## Recent Cleared Devices (20 of 62) Showing 20 most recent of 62 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252270](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K252270.md) | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | Apr 8, 2026 | SESE | | [K253734](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K253734.md) | Taurus Clip | Taurus Endoscopy | Mar 12, 2026 | SESE | | [K251562](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K251562.md) | OTSCneo System Set (100.03n-14n, 100.27n-31n) | Ovesco Endoscopy AG | Dec 18, 2025 | SESE | | [K252271](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K252271.md) | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | Nov 12, 2025 | SESE | | [K250229](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K250229.md) | Dual Action Tissue Closure Device | Micro-Tech (Nanjing) Co., Ltd. | Sep 8, 2025 | SESE | | [K250842](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K250842.md) | PADLOCK CLIP EFTR Kit (00713229) | STERIS Corporation | Apr 18, 2025 | SESE | | [K250066](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K250066.md) | Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612) | Boston Scientific Corporation | Feb 6, 2025 | SESE | | [K241005](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K241005.md) | Haemostasis Clips | Jiangxi Zhuoruihua Medical Instrument Co., Ltd. | Jan 2, 2025 | SESE | | [K240274](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K240274.md) | PADLOCK CLIP EFTR Kit (00713229) | STERIS Corporation | Sep 17, 2024 | SESE | | [K241858](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K241858.md) | BARS Set (100.60) | Ovesco Endoscopy AG | Aug 26, 2024 | SESE | | [K234124](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K234124.md) | Single Use Hemoclips | Promisemed Hangzhou Meditech Co., Ltd. | Jul 12, 2024 | SESE | | [K232969](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K232969.md) | Disposable Hemostatic Clips | Ningbo Xinwell Medical Technology Co., Ltd. | Jun 7, 2024 | SESE | | [K240617](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K240617.md) | 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) | Olympus Medical Systems Corp. | Jun 3, 2024 | SESE | | [K233772](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K233772.md) | Disposable Dual Action Tissue Closure Device | Mirco-Tech (Nanjing) Co., Ltd. | Mar 19, 2024 | SESE | | [K232450](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K232450.md) | Disposable Hemostatic Clips | Zhejiang Soudon Medical Technology Co., Ltd. | Jan 26, 2024 | SESE | | [K231633](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K231633.md) | Disposable Hemoclip (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. | Jan 11, 2024 | SESE | | [K230004](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K230004.md) | Disposable Hemoclip | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Jul 31, 2023 | SESE | | [K222146](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K222146.md) | Disposable Endoscopic Hemoclip | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Mar 28, 2023 | SESE | | [K213217](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K213217.md) | Disposable hemoclip | Beijing Zksk Technology Co., Ltd. | Nov 14, 2022 | SESE | | [K222503](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K222503.md) | Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip | Boston Scientific Corporation | Sep 14, 2022 | SESE | ## Top Applicants - Boston Scientific Corporation — 8 clearances - Micro-Tech (Nanjing) Co., Ltd. — 8 clearances - Ovesco Endoscopy AG — 8 clearances - Hangzhou AGS MedTech Co., Ltd. — 5 clearances - STERIS Corporation — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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