GAW · Suture, Nonabsorbable, Synthetic, Polypropylene

Device class

Class II

Regulation 878.5010

Total clearances

2020-03-19 → 2026-03-27

Last 12 months

Unique sponsors

Classification details

Medical specialty

General, Plastic Surgery

Review panel

Regulation number

878.5010

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Aptos, LLC	1	0	2020-08-27
Cypris Medical	1	0	2024-01-12
Msi	1	0	2022-09-02
Lydus Medical , Ltd.	1	0	2022-12-09
ETHICON, Inc.	1	1	2026-03-27
Shandong Haidike Medical Products Co., Ltd.	1	0	2023-09-14
Teleflex Medical	1	0	2020-03-19

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.

Code	Type	Description	Confidence	Rationale
99070	CPT	—	High	Nonabsorbable polypropylene sutures typically billed as surgical supplies

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-03-27	K253572	ETHICON, Inc.	STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device
2024-01-12	K233355	Cypris Medical	Cypris eXact Suturing System
2023-09-14	K230746	Shandong Haidike Medical Products Co., Ltd.	Non absorbable Surgical Polypropylene Suture
2022-12-09	K221280	Lydus Medical , Ltd.	Vesseal
2022-09-02	K211178	Msi	DURAMESH Mesh Suture
2020-08-27	K192953	Aptos, LLC	APTOS Threads Polypropylene Surgical Sutures
2020-03-19	K193530	Teleflex Medical	Deklene MAXX