510(k) Report

Devices descending from K192945

5 later devices reach 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242480FLASH EVD System (10-0002)7D Surgical ULC20240—
+1K230661Zeta Cranial Navigation SystemZeta Surgical20233—
+2K233903Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc.20242—
+3K242351Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc.20241—
+4K253663Zeta Navigation SystemZeta Surgical, Inc.20260—