Product code PLI— Gastroenterology, Urology

DALE GASTROSTOMY TUBE HOLDER

Classification name: Gastrointestional Tube Holder
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Total cleared: 1
First cleared: 1996-07-30
Most recent: 1996-07-30

FDA classification definition

“Intended to support, secure, and hold gastrointestinal tubes”
— U.S. Food and Drug Administration, device classification record for product code PLI under 21 CFR 876.5980, via openFDA

Market context for product code PLI

FDA has cleared 1 device under product code PLI, all in 1996, filed by 1 applicant company. 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.

Top applicants under product code PLI

Dale Medical Products, Inc.1 clearance

Recent clearances under product code PLI

K961693 — DALE GASTROSTOMY TUBE HOLDERDale Medical Products, Inc.·1996-07-30

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