Device class
Class II
Regulation 876.5885
Total clearances
4
2021-09-20 → 2024-09-06
Classification details
Medical specialty
Gastroenterology, Urology
Regulation number
876.5885
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Yocon Biology Technology Company |
1 |
0 |
2024-09-06 |
|
Energy Delivery Solutions |
1 |
0 |
2021-09-20 |
|
Duogenic Stemcells Corporation |
1 |
0 |
2024-07-12 |
|
Fujifilm Irvine Scientific
|
1 |
0 |
2023-11-09 |
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 |
| 87000 |
CPT
|
— |
Low
|
Culture media is often bundled into specimen-handling codes; no direct standalone billing code |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2024-09-06 |
K232543 |
Yocon Biology Technology Company
|
MSC SFM |
| 2024-07-12 |
K240247 |
Duogenic Stemcells Corporation
|
MoFi Cell Culture Basal Medium |
| 2023-11-09 |
K231804 |
Fujifilm Irvine Scientific
|
PRIME-XV FreezIS DMSO-Free MD |
| 2021-09-20 |
K201789 |
Energy Delivery Solutions
|
CT-STOR |