K853559Substantially Equivalent

Sterile Biopsy Needles

Name: K853559 Sterile Biopsy Needles
Creator: Plasmedics, Inc.
Published: 1985-09-11
License: https://open.fda.gov/license/

Plasmedics, Inc., Englewood CO / Traditional, Substantially Equivalent

FDA source

K853559 is the FDA 510(k) clearance record for STERILE BIOPSY NEEDLES, cleared for Plasmedics, Inc. on 1985-09-11. FDA records list 6 510(k) clearances for Plasmedics, Inc., from 1982-12-09 to 1985-09-11. As of 2026-09-10, FDA records show no recalls naming K853559.

Clearance record

Decision date: 1985-09-11
Received: 1985-08-26 (16 days to decision)
Review panel: Unknown
Applicant: Plasmedics, Inc. 6404 S. Quebec, Englewood CO
Third party review: No