510(k) Report

Devices descending from K130616

7 later devices reach Manual-Bone-Marrow-Biopsy-Needles, Semi-Automatic-Biopsy-Needles… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222462Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15)…Itp Innovative Tomography Products GmbH20231—
+1K203397Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or…Biopsybell S.R.L.20210—
+1K172344Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)Medax Srl Unipersonale20171—
+1K162588Möller Medical Biopsy Needles and SystemsMoller Medical GmbH20171—
+2K242128Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall…Xaga Surgical20250—
+2K233294Automatic Biopsy Needle BAM, Semi-Automatic Needle BIMItp Innovative Tomography Products GmbH20240—
+2K192099MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone…Medax Srl Unipersonale20200—