DeviceClearance

Product code PKL— Gastroenterology, Urology

Hemoclip

Classification name
Hemostatic Metal Clip For The Gi Tract
Device class
Class 2
Regulation
21 CFR 876.4400
Advisory panel
Gastroenterology, Urology
Total cleared
64
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PKL under 21 CFR 876.4400, via openFDA

Market context for product code PKL

FDA has cleared 64 devices under product code PKL between 1997 and 2026, filed by 28 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code PKL

Adverse events under product code PKL

product code PKL
Death
9
Injury
489
Malfunction
4,698
Other
1
Total
5,197

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code PKL

Data sourced from openFDA. This site is unofficial and independent of the FDA.