K864754Substantially Equivalent

Becker External Drainage & Monitor System Trocar

Name: K864754 Becker External Drainage & Monitor System Trocar
Creator: Pudenz-Schulte Medical Research Corp.
Published: 1986-12-22
License: https://open.fda.gov/license/

Pudenz-Schulte Medical Research Corp., Goleta CA / Traditional, Substantially Equivalent

FDA source

K864754 is the FDA 510(k) clearance record for BECKER EXTERNAL DRAINAGE & MONITOR SYSTEM TROCAR, cleared for Pudenz-Schulte Medical Research Corp. on 1986-12-22. FDA records list 40 510(k) clearances for Pudenz-Schulte Medical Research Corp., from 1980-01-16 to 1996-09-30. As of 2026-09-10, FDA records show no recalls naming K864754.

Clearance record

Decision date: 1986-12-22
Received: 1986-12-05 (17 days to decision)
Review panel: Unknown
Applicant: Pudenz-Schulte Medical Research Corp. P.O. Box 2090, Goleta CA
Third party review: No