Lukens Polypropylene Monofilament Nonabsorbable
FDA 510(k) K930941 · Lukens Medical Corp.
510(k) numberK930941
Submission
- Device name
- Lukens Polypropylene Monofilament Nonabsorbable
- Applicant
- Lukens Medical Corp.
Mahwah, NJ, US - Received
- February 23, 1993
- Decision date
- December 17, 1993
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K965162 | Lukens Pga, (Polyglycolic Acid) Synthetic Absorbable Surgical Suture,Coated…GAM · Traditional | 02/12/1997SE |
| K930945 | Braided Polyester Surgical SutureGAT · Traditional | 12/17/1993SE |
| K930944 | Lukens Surgical Gut SutureGAL · Traditional | 12/17/1993SE |
| K930943 | Lukens Nylon Surgical SutureGAR · Traditional | 12/17/1993SE |
| K930942 | Lukens Silk Surgical SutureGAT · Traditional | 12/17/1993SE |
| K930940 | Lukens Stainless Steel Surgical SutureGAQ · Traditional | 12/17/1993SE |
| K904535 | Lu-Tex IIGAS · Traditional | 01/30/1991SE |
Questions and answers
When was Lukens Polypropylene Monofilament Nonabsorbable cleared by the FDA?
Lukens Polypropylene Monofilament Nonabsorbable (K930941) received a 510(k) decision of Substantially Equivalent on December 17, 1993, 297 days after the submission was received.
What is the product code of K930941?
The FDA product code is GAW – Suture, Nonabsorbable, Synthetic, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 878.5010.