Non absorbable Surgical Silk Suture
FDA 510(k) K232355 · Shandong Haidike Medical Product Co., Ltd.
510(k) numberK232355
Submission
- Device name
- Non absorbable Surgical Silk Suture
- Applicant
- Shandong Haidike Medical Product Co., Ltd.
Heze, CN - Received
- August 7, 2023
- Decision date
- January 16, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAP – Suture, Nonabsorbable, Silk
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5030
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241486 | Sofsilk Coated Braided Silk SutureGAP · Traditional | Covidien | 12/03/2024SE |
| K222944 | SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture…GAP · Traditional | Safepath Medical, Inc. | 10/18/2024SE |
| K221767 | Surgical Sutures with or without NeedleGAP · Traditional | Huaian Seamen Medical Technology Co., Ltd. | 07/31/2023SE |
| K180701 | SafePath Suturing SystemGAP · Traditional | Safepath Medical, Inc. | 06/25/2018SE |
| K172149 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable…GAP · Special | M/s. Meril Endo Surgery Private Limited. | 10/20/2017SE |
| K162396 | SILK Surgical SutureGAP · Traditional | Teleflexmedical, Inc. | 11/23/2016SE |
| K160623 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable…GAP · Traditional | M/s. Meril Endo Surgery Private Limited. | 05/31/2016SE |
| K080684 | Wg-Surgical Sutures with NeedleGAP · Traditional | Foosin Medical Supplies, Inc. | 06/09/2008SE |
| K071111 | Non-Absorbable Silk SutureGAP · Traditional | Arrow Intl., Inc. | 07/17/2007SE |
| K053638 | Mani Needle & Suture Pack (Silk)GAP · Traditional | Mani, Inc. | 05/19/2006SE |
More from Mani, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K212603 | Non Absorbable Surgical Nylon SutureGAR · Traditional | 12/22/2021SE |
Questions and answers
When was Non absorbable Surgical Silk Suture cleared by the FDA?
Non absorbable Surgical Silk Suture (K232355) received a 510(k) decision of Substantially Equivalent on January 16, 2024, 162 days after the submission was received.
What is the product code of K232355?
The FDA product code is GAP – Suture, Nonabsorbable, Silk, a Class II (moderate risk) device regulated under 21 CFR 878.5030.