Chrysalis Intelligence · Product Codes · SAQ

SAQ · Electromechanical System For Open Microsurgery

General, Plastic Surgery · 5 clearances · 2 unique sponsors

Device class
Class II
Regulation 878.4963
Total clearances
5
2024-04-05 → 2025-11-10
Last 12 months
2
Unique sponsors
2
Definition

What is Electromechanical System For Open Microsurgery

An electromechanical system for open microsurgery is a software-controlled electromechanical system with bedside human/device interfaces and without an integrated visualization system which allows a qualified user to perform surgical techniques during open mircosurgical procedures using surgical instruments attached to an electromechanical arm.
Medical specialty
General, Plastic Surgery
Review panel
SU
Regulation number
878.4963
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
Medical Microinstruments, Inc. 4 2 2025-11-10
Mmi North America, Inc. 1 0 2024-04-05
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
0065T CPT Medium CPT for robotic surgical assistance, applicable to electromechanical arm-assisted microsurgery
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-11-10 K252287 Medical Microinstruments, Inc. Symani Surgical System
2025-09-04 K251510 Medical Microinstruments, Inc. Symani Surgical System
2025-02-07 K242368 Medical Microinstruments, Inc. Symani Surgical System
2025-01-27 K250014 Medical Microinstruments, Inc. Symani Surgical System (820-03830)
2024-04-05 DEN230032 Mmi North America, Inc. Symani Surgical System