Disposable Hemostatic Clips

510(k) Number

K232969 ↗

FDA product code

PKL

Device class

Class II

Regulation

21 CFR Part 876.4400

Advisory committee

Gastroenterology, Urology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code PKL (Hemostatic Metal Clip For The Gi Tract).

• Disposable Dual Action Tissue Clip by Micro-Tech (Nanjing) Co., Ltd.
• Disposable Hemoclip by Yangzhou Fartley Medical Instrument Technology Co., Ltd
• stentfix OTSC System Set 100.50 by Ovesco Endoscopy AG
• Disposable Dual Action Tissue Closure Device by Mirco-Tech (Nanjing) Co., Ltd.
• FTRD System Set by Ovesco Endoscopy AG
• Dual Action Tissue Closure Device by Micro-Tech (Nanjing) Co., Ltd.
• SINGLE USE REPOSITIONABLE CLIP by Olympus Medical Systems Corporation
• Super Short Clip HX-610-135XS N6012930 by Olympus Medical Systems Corporation
• Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device by STERIS CORPORATION
• Resolution Clip M00522600 by Boston Scientific

• Disposable Anesthetic Breathing Circuits

  Class IIa

  CE/MDR

• Single-Use Digital Flexible Ureteroscopes

  Class IIa

  CE/MDR

• Disposable Anesthetic Masks

  Class IIa

  CE/MDR

• Laryngoscope Blades

  Class IIa

  CE/MDR

See all devices from Ningbo Xinwell Medical Technology Co., Ltd. →