510(k) Report

Devices descending from K152133

13 later devices reach IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230551Visual-ICE Cryoablation SystemBoston Scientific Corporation20234—
+1K203032IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle…Galil Medical, Inc.20200—
+1K162599IcePearl 2.1 CX L, IceForce 2.1 CX LGalil Medical, Ltd.201612
+1K161480R2 Dermal Cooling SystemR2 Dermatology20165—
+2K250742Focused Cryotherapy SystemFocused Cryo, Inc.20250—
+2K234002ICEfx Cryoablation System (FPRCH8000-02)Boston Scientific202402
+2K232635IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)Boston Scientific202311
+2K171398Dermal Cooling SystemR2 Dermatology,Inc20174—
+3K243245IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle…Boston Scientific Corp20240—
+3K201260Dermal Cooling SystemR2 Technologies, Inc.20203—
+4K203006R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc.20212—
+5K213294Dermal Cooling SystemR2 Technologies, Inc.20221—
+6K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—