Chrysalis Intelligence · Product Codes · EWY

EWY · Mediastinoscope, Surgical

Ear, Nose, Throat · 3 clearances · 2 unique sponsors

Device class
Class II
Regulation 874.4720
Total clearances
3
2021-05-11 → 2026-03-02
Last 12 months
1
Unique sponsors
2
Definition

What is Mediastinoscope, Surgical

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Medical specialty
Ear, Nose, Throat
Review panel
EN
Regulation number
874.4720
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
Karl Storz Endoscopy America, Inc. 2 0 2022-06-23
Karl Storz SE & CO. KG 1 1 2026-03-02
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
39400 CPT High CPT code for mediastinoscopy including biopsy when performed
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-03-02 K260003 Karl Storz SE & CO. KG KARL STORZ Mediastinoscopes and Instruments
2022-06-23 K213194 Karl Storz Endoscopy America, Inc. HD Mediastinoscope
2021-05-11 K202272 Karl Storz Endoscopy America, Inc. HD Mediastinoscope