Ifsa Sterile Silk Braided Nonabsor Surg Sutures
FDA 510(k) K905287 · Internacional Farmaceutica, S.A. DE C.V.
510(k) numberK905287
Submission
- Device name
- Ifsa Sterile Silk Braided Nonabsor Surg Sutures
- Applicant
- Internacional Farmaceutica, S.A. DE C.V.
Great Neck, NY, US - Received
- November 26, 1990
- Decision date
- February 11, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Arrow Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K072863 | Atramat PGC25 Poly(Glycolide-Co-Epsilon-Caprolactone) Surgical SuturesGAM · Traditional | 05/23/2008SE |
| K072859 | Atramat PGLA90 Poly(Glycolide-Co-L-Lactide) Surgical SuturesGAM · Traditional | 05/23/2008SE |
| K041048 | Polydioxanone Synthetic Absorbable Surgical SutureNEW · Traditional | 06/04/2004SE |
| K040282 | Atramat and Sorb-Fast Polyglycolic AcidGAM · Traditional | 04/29/2004SE |
| K913185 | Sterile Stainless Steel Monofil Nonabsorb Surg SutGAQ · Traditional | 12/04/1991SE |
| K911354 | Sterile Plain Gut/Chromic Gut Absorb Surg SuturesGAL · Traditional | 10/25/1991SE |
| K911189 | Sterile Polypropylene Monfil Nonabsorb Surg SutureGAW · Traditional | 04/25/1991SE |
| K905286 | Ifsa Sterile Nlylon Monofil Nonabsor Surg SuturesGAR · Traditional | 02/11/1991SE |
| K905285 | Ifsa Sterile Braided Poly Nonabsor Surg SuturesGAS · Traditional | 02/11/1991SE |
Questions and answers
When was Ifsa Sterile Silk Braided Nonabsor Surg Sutures cleared by the FDA?
Ifsa Sterile Silk Braided Nonabsor Surg Sutures (K905287) received a 510(k) decision of Substantially Equivalent on February 11, 1991, 77 days after the submission was received.
What is the product code of K905287?
The FDA product code is GAP – Suture, Nonabsorbable, Silk, a Class II (moderate risk) device regulated under 21 CFR 878.5030.