Device class
Class II
Regulation 876.1500
Total clearances
5
2021-08-20 → 2026-08-10
Classification details
Medical specialty
Gastroenterology, Urology
Regulation number
876.1500
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Alcon Laboratories, Inc.
|
1 |
0 |
2024-12-04 |
|
Oculight , Ltd. |
1 |
0 |
2021-08-20 |
|
Nova Eye, Inc. |
1 |
1 |
2026-08-10 |
|
Nova Eye Inc. (Business Name Nova Eye Medical) |
1 |
0 |
2023-03-30 |
|
Peregrine Surgical, LLC |
1 |
0 |
2024-08-05 |
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 |
| 43235 |
CPT
|
— |
Medium
|
Upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate |
| A4649 |
HCPCS
|
Surgical supply; miscellaneous ✓ CMS-verified description |
Medium
|
Endoscope light source (reusable/special endoilluminator) |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-08-10 |
K253468 |
Nova Eye, Inc.
|
Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A) |
| 2024-12-04 |
K242184 |
Alcon Laboratories, Inc.
|
Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); |
| 2024-08-05 |
K233653 |
Peregrine Surgical, LLC
|
Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) |
| 2023-03-30 |
K221872 |
Nova Eye Inc. (Business Name Nova Eye Medical)
|
ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System |
| 2021-08-20 |
K202670 |
Oculight , Ltd.
|
Nam illumination probe with chopper |