510(k) Report

Devices descending from K010735

9 later devices reach Speedybell through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162588Möller Medical Biopsy Needles and SystemsMoller Medical GmbH20171—
+1K130616Manual-Bone-Marrow-Biopsy-Needles, Semi-Automatic-Biopsy-Needles, Automatic-Biopsy-NeedlesBiopsybell S.R.L.201472
+1K102771Biopsy Handy, Mri Biopsy HandySomatex Medical Technologies GmbH20110—
+2K242128Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall…Xaga Surgical20250—
+2K222462Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15)…Itp Innovative Tomography Products GmbH20231—
+2K203397Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or…Biopsybell S.R.L.20210—
+2K172344Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)Medax Srl Unipersonale20171—
+3K233294Automatic Biopsy Needle BAM, Semi-Automatic Needle BIMItp Innovative Tomography Products GmbH20240—
+3K192099MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone…Medax Srl Unipersonale20200—