Atlas FDA

Asurys Fluid Management System

FDA 510(k) clearance K251273 · decided 2026-03-27

Clearance details

K-number
K251273
Device name
Asurys Fluid Management System
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2025-04-24
Decision date
2026-03-27
Days to decision
337 days
Clearance type
Traditional
Product code
HIG
Device class
2
Regulation number
884.1700
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Marborough, MA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Boston Scientific Corporation

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
Endomat Select (UP220) (K261706)KARL STORZ SE & CO. KG2026-07-16
Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) (K240886)Hologic, Inc.2024-07-25
X-FLO Fluid Management System (K210628)Thermedx, LLC2021-11-04
Endomat Select, IBS Shaver Software, License (K201355)Karl Storz SE & CO. KG2020-07-22
Endomat Select (K180735)Karl Storz SE & CO. KG2018-10-31
Fluent Fluid Management System (K180825)Hologic, Inc.2018-08-03
GYN-Pump PH304 (K173489)W.O.M. World of Medicine GmbH2018-03-28
Aquilex Fluid Control System AQL-100S (K172040)W.O.M. World of Medicine GmbH2018-02-05
FluidSmart (K172048)Thermedx, LLC2017-09-05
THERMEDX FLUID MANAGMENT SYSTEM (K133799)Thermedx, LLC2014-06-20
HYSTEROSCOPY PUMP HM6 (K123732)W.O.M. World of Medicine AG2013-04-04
AQUILEX FLUID CONTROL SYSTEM H112 (K112642)W.O.M. World of Medicine AG2012-02-06

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Axonics Sacral Neuromodulation System (P190006/S101)Boston Scientific Corporation2025-12-19
Axonics Sacral Neuromodulation System (P180046/S101)Boston Scientific Corporation2025-12-19
SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S110)Boston Scientific Corporation2025-10-29
Innova™ Vascular Self-Expanding Stent System (P140028/S084)Boston Scientific Corporation2025-10-24
Ranger™ Paclitaxel-Coated PTA Balloon Catheter (P190019/S039)Boston Scientific Corporation2025-10-24
AGENT™ Paclitaxel-Coated Balloon Catheter (P230035/S007)Boston Scientific Corporation2025-10-24
ENROUTE® Transcarotid Stent System (P140026/S032)Boston Scientific Corporation2025-10-23
A209 SICD Gen 2,A219 SICD MRI (P110042/S206)Boston Scientific Corporation2025-10-22