Device class
Class II
Regulation 884.1700
Total clearances
5
2020-07-22 → 2026-07-16
Classification details
Medical specialty
Obstetrics/Gynecology
Regulation number
884.1700
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 58555 |
CPT
|
— |
Medium
|
Hysteroscopic procedure codes; insufflator provides distension medium |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-07-16 |
K261706 |
KARL STORZ SE & CO. KG
|
Endomat Select (UP220) |
| 2026-03-27 |
K251273 |
Boston Scientific Corporation
|
Asurys Fluid Management System |
| 2024-07-25 |
K240886 |
Hologic, Inc.
|
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) |
| 2021-11-04 |
K210628 |
Thermedx, LLC
|
X-FLO Fluid Management System |
| 2020-07-22 |
K201355 |
Karl Storz SE & CO. KG
|
Endomat Select, IBS Shaver Software, License |