Hemostatic Metal Clip For The Gi Tract

PKL · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.4400

Classification

FDA Product Code: PKL
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.4400
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 1
GMP exempt: N
Life sustaining: Y
Implant: Y
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 62
Registered establishments: 53

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown