Chrysalis Intelligence · Product Codes · ERL

ERL · Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Ear, Nose, Throat · 7 clearances · 7 unique sponsors

Device class
Class II
Regulation 874.4250
Total clearances
7
2020-10-22 → 2025-07-03
Last 12 months
0
Unique sponsors
7
Medical specialty
Ear, Nose, Throat
Review panel
EN
Regulation number
874.4250
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Zethon, Ltd. 1 0 2024-03-14
Gyrus Acmi, Inc. 1 0 2022-01-19
Bien-Air Surgery SA 1 0 2022-11-02
W&H Dentalwerk Buermoss GmbH 1 0 2022-05-26
Stryker Corporation 1 0 2021-06-09
W&H Dentalwerk Buermoos GmbH 1 0 2025-07-03
KARL STORZ Endoscopy-America, Inc. 1 0 2020-10-22
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
69535 CPT High Tympanoplasty without ossiculoplasty; ENT surgical drill used in mastoid/skull base procedures
61581 CPT Medium Craniotomy; surgical drill for sinus/temporal bone surgery
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-07-03 K243280 W&H Dentalwerk Buermoos GmbH Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)
2024-03-14 K233958 Zethon, Ltd. hekaDrill
2022-11-02 K221184 Bien-Air Surgery SA ORiGO System
2022-05-26 K213221 W&H Dentalwerk Buermoss GmbH AMADEO, M-UK1015 (incl. attachments and accessories)
2022-01-19 K212650 Gyrus Acmi, Inc. Celeris, Disposable Sinus Debrider
2021-06-09 K211490 Stryker Corporation Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000
2020-10-22 K200318 KARL STORZ Endoscopy-America, Inc. UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece