Chrysalis Intelligence · Product Codes · PKR

PKR · Unclassified

3 clearances · 1 unique sponsors

Device class
Regulation —
Total clearances
3
2020-03-26 → 2021-09-10
Last 12 months
0
Unique sponsors
1
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Electrocore, Inc. 3 0 2021-09-10
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
64568 CPT High Vagus nerve stimulation (VNS) pulse generator implantation or revision applicable
64569 CPT Medium Vagus nerve stimulation electrode implantation (non-invasive device related)
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2021-09-10 K211856 Electrocore, Inc. gammaCore Sapphire
2021-02-12 K203546 Electrocore, Inc. gammaCore Sapphire
2020-03-26 K191830 Electrocore, Inc. gammaCore Sapphire