Device class
Class II
Regulation 878.5020
Total clearances
5
2020-05-29 → 2026-06-03
Classification details
Medical specialty
General, Plastic Surgery
Regulation number
878.5020
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Tas Medical, Inc.
|
2 |
1 |
2026-06-03 |
|
Kono Seisakusho Co., Ltd. |
1 |
0 |
2020-05-29 |
|
Antarma, LLC Dba Golnit Sutures |
1 |
0 |
2022-03-31 |
|
Shandong Haidike Medical Product Co., Ltd. |
1 |
0 |
2021-12-22 |
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 |
| 99070 |
CPT
|
— |
High
|
Nonabsorbable polyamide (nylon) sutures typically billed as surgical supplies |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-06-03 |
K261484 |
Tas Medical, Inc.
|
Tissue Approximation System |
| 2023-07-05 |
K220980 |
Tas Medical, Inc.
|
Tissue Approximation System (TAS) |
| 2022-03-31 |
K212888 |
Antarma, LLC Dba Golnit Sutures
|
Golnit Nylon Monofilament Suture |
| 2021-12-22 |
K212603 |
Shandong Haidike Medical Product Co., Ltd.
|
Non Absorbable Surgical Nylon Suture |
| 2020-05-29 |
K192420 |
Kono Seisakusho Co., Ltd.
|
Crownjun Nylon Suture |