Chrysalis Intelligence · Product Codes · PNL

PNL · Magnetic Surgical System

General, Plastic Surgery · 4 clearances · 1 unique sponsors

Device class
Class II
Regulation 878.4815
Total clearances
4
2020-04-01 → 2025-09-26
Last 12 months
1
Unique sponsors
1
Definition

What is Magnetic Surgical System

System designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients within a BMI range of 20 to 34 kg/m2. The device is intended for prescription use only.
Medical specialty
General, Plastic Surgery
Review panel
SU
Regulation number
878.4815
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
Levita Magnetics International Corp 4 1 2025-09-26
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
47562 CPT Medium Laparoscopic cholecystectomy with specialized instrumentation for visualization and retraction
56637 CPT Medium Laparoscopic cholecystectomy; magnetic surgical system as adjunctive retraction device
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-09-26 K252435 Levita Magnetics International Corp Magnetic Surgical System
2025-06-07 K250746 Levita Magnetics International Corp Magnetic Surgical System
2023-08-04 K223673 Levita Magnetics International Corp Surgeon Controlled Arm
2020-04-01 K191762 Levita Magnetics International Corp Magnetic Surgical System