Asurys Fluid Management System
510(k) K251273
Asurys Fluid Management System is a medical device (FDA Class II; FDA product code HIG, Insufflator, Hysteroscopic) made by Boston Scientific, cleared under FDA 510(k) K251273 on 27 Mar 2026, active as of 9 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK251273 | Date27 Mar 2026 | StatusActive |
Official records
- FDA 510(k) database K251273
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HIG
- FDA applicant
- Boston Scientific Corporation
- Device class
- Class II
- Regulation
- 21 CFR Part 884.1700
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- SESE Substantially Equivalent
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- REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA by Washington Regulatory Services
- THERMEDX FLUID MANAGMENT SYSTEM by Thermedx, LLC
- INSUFFLATOR TUBING KIT by O.R. Concepts, Inc.
- Fluent Fluid Management System FLT-112S by Hologic