Atlas FDA

IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)

FDA 510(k) clearance K243245 · decided 2024-10-18

Clearance details

K-number
K243245
Device name
IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)
Applicant
Boston Scientific Corp
Decision
Substantially Equivalent
Date received
2024-10-11
Decision date
2024-10-18
Days to decision
7 days
Clearance type
Special
Product code
GEH
Device class
2
Regulation number
878.4350
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Maple Grove, MN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Boston Scientific Corp

The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) (K261068)Serpex Medical2026-06-30
ERBECRYO 2 Cryosurgical Unit and Accessories (K261806)Erbe Elektromedizin GmbH2026-06-09
ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe (K253230)Erbe Elektromedizin GmbH2026-04-22
Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) (K252198)Medical Brands Laboratories B.V.2026-04-02
XSense Cryoablation System with CryoProbes (K260377)IceCure Medical , Ltd.2026-02-24
CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) (K251928)Medinice S.A.2026-02-13
Dr. Yglo Skin Tag Remover (K251524)Theotclab Healthcare B.V.2026-01-12
Focused Cryotherapy System (K250742)Focused Cryo, Inc.2025-12-09
CryoFreeze Wart and Skin Tag Remover (K253000)Cryosurgery, Inc.2025-10-16
TargetCool™ (RM-DT02W) (K253114)Recensmedical, Inc.2025-10-16
TargetCool-e (K253348)Recensmedical, Inc.2025-10-15
Verruca-Freeze H Plus (K252903)Cryosurgery, Inc.2025-10-10

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Epic™ Vascular Self-Expanding Stent System (P110035/S078)Boston Scientific Corp2026-08-06
Eluvia™ Drug-Eluting Vascular Stent System (P180011/S069)Boston Scientific Corp2026-08-06
MOMENTUM™ CRT-D IS1 DF4 IS1 (G124, G125); MOMENTUM™ CRT-D IS1 DF1 LV1 (G126); MOMENTUM™ X4 CRT-D IS1 DF1 IS4 (G128, G138 (P010012/S613)Boston Scientific Corp2026-07-23
ESSENTIO™ SR SL (L100); ESSENTIO™ DR SL (L101); ESSENTIO™ DR EL (L121); PROPONENT™ SR SL (L200); PROPONENT™ DR SL (L201) (N970003/S309)Boston Scientific Corp2026-07-23
WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX™ Pro Left Atrial Appendage Closure (P130013/S086)Boston Scientific Corp2026-07-21
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S096)Boston Scientific Corp2026-07-16
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S397)Boston Scientific Corp2026-07-10
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S095)Boston Scientific Corp2026-07-10