Product code PKL

Device name

Hemostatic Metal Clip For The Gi Tract

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.4400

Review panel

GU

Implant

Y

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding tubes, supplemental closure method of luminal perforations.

Source

FDA openFDA device classification dataset