Grams Polypropylene Nonabsorbable Suture
FDA 510(k) K002999 · Gramsmed, LLC
510(k) numberK002999
Submission
- Device name
- Grams Polypropylene Nonabsorbable Suture
- Applicant
- Gramsmed, LLC
Grafton, WI, US - Received
- September 26, 2000
- Decision date
- December 18, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K021043 | Grams Absorbable Surgical Gut Suture Plain & ChromicGAL · Traditional | 06/21/2002SE |
| K010672 | Monograms Synthetic Monofilament Absorbable SutureGAM · Traditional | 05/18/2001SE |
| K003017 | Gramsorb Synthetic Absorbable SutureGAM · Traditional | 03/13/2001SE |
| K003590 | Grams Polyester Nonabsorbable SutureGAT · Traditional | 03/05/2001SE |
| K003000 | Grams Nylon Nonabsorbable SutureGAR · Traditional | 12/18/2000SE |
| K003001 | Grams Silk Nonabsorbable SutureGAP · Traditional | 12/15/2000SE |
Questions and answers
When was Grams Polypropylene Nonabsorbable Suture cleared by the FDA?
Grams Polypropylene Nonabsorbable Suture (K002999) received a 510(k) decision of Substantially Equivalent on December 18, 2000, 83 days after the submission was received.
What is the product code of K002999?
The FDA product code is GAW – Suture, Nonabsorbable, Synthetic, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 878.5010.