Chrysalis Intelligence · Product Codes · SDD

SDD · Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field

General, Plastic Surgery · 5 clearances · 1 unique sponsors

Device class
Class II
Regulation 878.4965
Total clearances
5
2024-10-25 → 2026-08-11
Last 12 months
3
Unique sponsors
1
Definition

What is Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field

An electromechanical surgical system with transient sterile field presence of both surgeon and primary control interface is a software-controlled electromechanical system with fully positionable patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures. The device allows for both the surgeon and primary control interface to have presence inside the sterile field as needed within the clinical context of use.
Medical specialty
General, Plastic Surgery
Review panel
SU
Regulation number
878.4965
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Distalmotion SA 5 3 2026-08-11
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.

CodeTypeDescriptionConfidenceRationale
22899 CPT Low Electromechanical surgical systems are typically billed under general surgical procedure codes; device-specific codes vary
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-08-11 K261398 Distalmotion SA Dexter L6 System
2026-06-11 K260653 Distalmotion SA Dexter L6 System
2025-09-30 K251197 Distalmotion SA Dexter L6 System
2025-05-27 K250435 Distalmotion SA Dexter L6 System
2024-10-25 DEN230084 Distalmotion SA Dexter L6 System