DeviceClearance

CORE BIOPSY NEEDLE, CATALOG CODE #54006— 510(k) K891537

Substantially Equivalent

Dlp, Inc.

FDA 510(k) clearance K891537 for CORE BIOPSY NEEDLE, CATALOG CODE #54006, Substantially Equivalent on 1989-04-18. Applicant: Dlp, Inc.. Device class: 1.

Clearance details

Applicant
Dlp, Inc.
Product code
Code GDM
Device class
Class 1
Regulation
21 CFR 878.4800
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Grand Rapids, MI, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code GDM

view all

More clearances from Dlp, Inc.

view all

Adverse events under product code GDM

product code GDM
Death
2
Total
2

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 →

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