Device class
Class II
Regulation 874.3620
Total clearances
6
2020-07-20 → 2024-07-24
Classification details
Medical specialty
Ear, Nose, Throat
Regulation number
874.3620
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
International Medical Devices, Inc. |
2 |
0 |
2023-02-03 |
|
Metalware Technology Corp. |
1 |
0 |
2020-07-20 |
|
Augmenta, LLC |
1 |
0 |
2022-09-30 |
|
Shineo Technology Co., Ltd. |
1 |
0 |
2022-12-23 |
|
Keosan Trading Co. |
1 |
0 |
2024-07-24 |
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 |
| 20999 |
CPT
|
— |
Low
|
CPT for unlisted orthopedic procedure; silicone block elastomer is specialized material without standard code |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2024-07-24 |
K241150 |
Keosan Trading Co.
|
MISTI Silicone Implant |
| 2023-02-03 |
K223051 |
International Medical Devices, Inc.
|
Pre-Formed Silicone Block |
| 2022-12-23 |
K222748 |
Shineo Technology Co., Ltd.
|
ShiNeo Silicone Implant |
| 2022-09-30 |
K200073 |
Augmenta, LLC
|
AugMENTA Penile Implant |
| 2022-05-13 |
K220760 |
International Medical Devices, Inc.
|
Pre-Formed Penile Silicone Block |
| 2020-07-20 |
K193392 |
Metalware Technology Corp.
|
BioSiCar Silicone Implant |