510(k) Report

Devices descending from K980004

3 later devices reach Manan General Purpose Introducer Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162588Möller Medical Biopsy Needles and SystemsMoller Medical GmbH20171—
+1K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc.20050—
+2K242128Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall…Xaga Surgical20250—