FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture
FDA 510(k) K172149 · M/s. Meril Endo Surgery Private Limited.
510(k) numberK172149
Submission
- Device name
- FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture
- Applicant
- M/s. Meril Endo Surgery Private Limited.
Chala, Vapi, IN - Received
- July 17, 2017
- Decision date
- October 20, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K232355 | Non absorbable Surgical Silk SutureGAP · Traditional | Shandong Haidike Medical Product Co., Ltd. | 01/16/2024SE |
| 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 |
| 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 |
|---|---|---|
| K252644 | PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION…NEW · Special | 09/23/2025SE |
| K233386 | Monik - Disposable Endoscopic TrocarGCJ · Traditional | 05/24/2024SE |
| K232246 | 1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2)…NEW · Traditional | 04/25/2024SE |
| K230981 | Meriglu Topical Skin AdhesiveMPN · Traditional | 03/16/2024SE |
| K200452 | Meril-BonewaxMTJ · Traditional | 03/27/2023SE |
| K200320 | Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular…GDW · Traditional | 02/05/2021SE |
| K200166 | Mirus Ligating Clip, Mirus Ligating Clip ApplierFZP · Traditional | 11/23/2020SE |
| K172146 | MeristeelGAQ · Traditional | 02/01/2018SE |
| K172659 | MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable…GAM · Special | 09/28/2017SE |
| K160623 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable…GAP · Traditional | 05/31/2016SE |
Questions and answers
When was FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture cleared by the FDA?
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture (K172149) received a 510(k) decision of Substantially Equivalent on October 20, 2017, 95 days after the submission was received.
What is the product code of K172149?
The FDA product code is GAP – Suture, Nonabsorbable, Silk, a Class II (moderate risk) device regulated under 21 CFR 878.5030.