Polycryl
by Aurolab
510(k) K140039
Polycryl is a Class II device made by Aurolab, cleared under FDA 510(k) K140039 on 15 Sep 2014 and listed in FDA GUDID since 12 Dec 2020 (UDI-DI 00803878041638), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number00803878041638 | Date12 Dec 2020 | StatusListed |
| United States | FDA 510(k)SESE 510(k) | NumberK140039 | Date15 Sep 2014 | StatusActive |
Official records
- AccessGUDID record 00803878041638
- FDA 510(k) database K140039
Across registries
- FDA 510(k) K140039 decided 15 Sep 2014 Active
- FDA GUDID UDI-DI 00803878041638 listed 12 Dec 2020 Listed
Timeline
- Cleared FDA 510(k) K140039
- Listed FDA GUDID 00803878041638
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Nylon suture, non-bioabsorbable, monofilament
- Model / reference
- A5108
- Primary DI / UDI-DI
- 00803878041638
- 510(k) Number
- FDA product code
- GAM
- GMDN term
- Nylon suture, non-bioabsorbable, monofilament
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4493
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
- GUDID distribution status
- In Commercial Distribution
Devices cleared under K140039
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Polycryl A5108 | A5108 | 00803878041638 | — | On the market |
| Polycryl A6108 | A6108 | 00803878029025 | — | On the market |
| Polycryl A6409 | A6409 | 00803878029032 | — | On the market |
| Polycryl A7102 | A7102 | 00803878029049 | — | On the market |
| Polycryl A8104 | A8104 | 00803878029063 | — | On the market |
| U.S. IOL, Inc. US-6002LZV | US-6002LZV / US-6002LZV | 00814106016069 | — | On the market |
| U.S. IOL, Inc. US-7002LZV | US-7002LZV / US-7002LZV | 00814106016083 | — | On the market |
| U.S. IOL, Inc. US-8002LZV | US-8002LZV / US-8002LZV | 00814106016106 | — | On the market |
| U.S. IOL, Inc. US-9002LZV | US-9002LZV / US-9002LZV | 00814106016120 | — | On the market |
Similar devices
Other devices filed under FDA product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid).
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- STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device by Ethicon Inc.
- MONODERM SURGICAL SUTURE by Surgical Specialties Corp
- WEGO-PGA Absorbable Surgical Suture With Needle G3007005 by Foosin Medical Supplies, Inc.