Chrysalis Intelligence · Product Codes · FEB

FEB · Accessories, Cleaning, For Endoscope

Gastroenterology, Urology · 6 clearances · 5 unique sponsors

Device class
Class II
Regulation 876.1500
Total clearances
6
2020-03-30 → 2024-12-19
Last 12 months
0
Unique sponsors
5
Definition

What is Accessories, Cleaning, For Endoscope

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
Gastroenterology, Urology
Review panel
HO
Regulation number
876.1500
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
STERIS Corporation 2 0 2024-12-02
Custom Ultrasonics, Inc. 1 0 2020-03-30
Olympus Medical Systems Corp. 1 0 2020-09-01
Medivators, Inc. 1 0 2022-01-14
Wassenburg Medical, Inc. 1 0 2024-12-19
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
C1770 HCPCS Imaging coil, magnetic resonance (insertable) ✓ CMS-verified description Medium Endoscope cleaning/reprocessing supplies as supply code
E1640 HCPCS Medium DME rental/supply code for endoscope cleaning equipment
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2024-12-19 K241168 Wassenburg Medical, Inc. System 83 Revolve Endoscope Washer/Disinfector
2024-12-02 K243433 STERIS Corporation enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System
2023-06-30 K230930 STERIS Corporation enspire 3000 Cleaning and Liquid Chemical Sterile Processing System
2022-01-14 K213833 Medivators, Inc. SCOPE BUDDY PLUS Endoscope Flushing Aid
2020-09-01 K201920 Olympus Medical Systems Corp. Endoscope Reprocessor OER-Elite
2020-03-30 K173590 Custom Ultrasonics, Inc. System 83 Plus Washer/Disinfector