510(k) Report

Devices descending from K955065

12 later devices reach Olympus FB Series Biopsy Forceps through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042659Medisiss Reprocessed Non-Electric GI Biopsy ForcepsMedisiss20050—
+1K012074XBO1-824-18/19/20 Biopsy ForcepsThe Olympus Optical Co.20010—
+1K962555Olympus FB Series Biopsy ForcepsOlympus America, Inc.19969—
+2K173760Monarch Endoscopy Platform (Monarch Platform)Auris Surgical Robotics, Inc.201871
+2K022398Reusable Bronchial Biopsy ForcepsBallard Medical Products20020—
+3K223144Galaxy SystemNoah Medical Corp.202305
+3K193534Monarch PlatformAuris Health, Inc.202054
+4K231473Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company202301
+4K211493Monarch PlatformAuris Health, Inc.202122
+4K203614Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company20211—
+5K243219MONARCH™ Platform (MON-000008)Auris Health, Inc.202511
+6K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.20260—