Device class
Class II
Regulation 876.1500
Total clearances
5
2020-05-14 → 2023-10-03
Definition
What is Accessories, Germicide, Cleaning, For Endoscopes
High level disinfection of reusable, heat-sensitive devices 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).
Classification details
Medical specialty
Gastroenterology, Urology
Regulation number
876.1500
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
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.
| Code | Type | Description | Confidence | Rationale |
| A4649 |
HCPCS
|
Surgical supply; miscellaneous ✓ CMS-verified description |
Low
|
Endoscope cleaning/disinfection accessory; typically included in facility reprocessing costs |
Pulse
Most recent 510(k) clearances