Mopylen
FDA 510(k) K922630 · S. Jackson, Inc.
510(k) numberK922630
Submission
- Device name
- Mopylen
- Applicant
- S. Jackson, Inc.
Alexandria, VA, US - Received
- June 3, 1992
- Decision date
- October 20, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GAW – Suture, Nonabsorbable, Synthetic, Polypropylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5010
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253572 | STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX…GAW · Traditional | ETHICON, Inc. | 03/27/2026SE |
| K233355 | Cypris eXact Suturing SystemGAW · Traditional | Cypris Medical | 01/12/2024SE |
| K230746 | Non absorbable Surgical Polypropylene SutureGAW · Traditional | Shandong Haidike Medical Products Co., Ltd. | 09/14/2023SE |
| K221280 | VessealGAW · Traditional | Lydus Medical , Ltd. | 12/09/2022SE |
| K211178 | DURAMESH Mesh SutureGAW · Traditional | Msi | 09/02/2022SE |
| K192953 | APTOS Threads Polypropylene Surgical SuturesGAW · Traditional | Aptos, LLC | 08/27/2020SE |
| K193530 | Deklene MAXXGAW · Special | Teleflex Medical | 03/19/2020SE |
| K191299 | Silhouette Featherlift / Silhouette LiftGAW · Special | Silhouette Lift, Inc. | 06/14/2019SE |
| K173747 | RexleneGAW · Traditional | Sm Eng Co., Ltd. | 12/21/2018SE |
| K180321 | Aesculap Optilene Nonabsorbable SutureGAW · Special | Aesculap, Inc. | 03/07/2018SE |
More from Aesculap, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K080216 | Supramesh ExtraFTL · Traditional | 09/15/2008SE |
| K973379 | Sterile Suprafoil Smooth Nylon Foil SheetsFTM · Traditional | 09/25/1997SE |
| K931614 | Mopylen SutureGAW · Traditional | 12/17/1993SE |
| K931613 | Supramid SutureGAR · Traditional | 12/17/1993SE |
| K931612 | Nylamid SutureGAR · Traditional | 12/17/1993SE |
| K912429 | N80-838 Supramid Extra SutureGAR · Traditional | 10/02/1991SE |
| K904052 | Supramid Extra SuturesGAR · Traditional | 10/25/1990SE |
| K852011 | Nylamid Mesh Pad Full & HalfFTM · Traditional | 06/11/1985SE |
| K831725 | Foil in 3 Forms-Non-Sterile SheetsFTM · Traditional | 08/16/1983SE |
| K831727 | Quarter Globe CapsFTM · Traditional | 08/12/1983SE |
Questions and answers
When was Mopylen cleared by the FDA?
Mopylen (K922630) received a 510(k) decision of Substantially Equivalent on October 20, 1992, 139 days after the submission was received.
What is the product code of K922630?
The FDA product code is GAW – Suture, Nonabsorbable, Synthetic, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 878.5010.