Suture Cord
FDA 510(k) K953128 · Phoenix Biomedical Corp.
510(k) numberK953128
Submission
- Device name
- Suture Cord
- Applicant
- Phoenix Biomedical Corp.
Valley Forge, PA, US - Received
- July 6, 1995
- Decision date
- February 9, 1996
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- GAS – Suture, Nonabsorbable, Synthetic, Polyester
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5000
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203120 | RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD…GAS · Special | Lsi Solutions, Inc. | 11/24/2020SE |
| K203081 | RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical SutureGAS · Special | Lsi Solutions | 11/24/2020SE |
| K091018 | Arthrex BiowireGAS · Traditional | Arthrex, Inc. | 07/30/2010SE |
| K002261 | Mr-IiiGAS · Traditional | Smith & Nephew, Inc. | 10/23/2000SE |
| K923161 | Braided Polyester Suture MaterialGAS · Traditional | Mitek Surgical Products, Inc. | 12/30/1992SE |
| K913101 | Peters Cardioflon(Tm) SutureGAS · Traditional | Promedica Products, Inc. | 08/12/1992SE |
| K915089 | Mitek Quickanchor(Tm), ModificationGAS · Traditional | Mitek Surgical Products, Inc. | 02/03/1992SE |
| K915081 | Mitek Snap Pak(Tm), ModificationGAS · Traditional | Mitek Surgical Products, Inc. | 01/31/1992SE |
| K903175 | Advance Suture Nonabsorbable Dacron SutureGAS · Traditional | Advance Suture, Inc. | 07/26/1991SE |
| K905285 | Ifsa Sterile Braided Poly Nonabsor Surg SuturesGAS · Traditional | Internacional Farmaceutica, S.A. DE C.V. | 02/11/1991SE |
More from Internacional Farmaceutica, S.A. DE C.V.
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| K033017 | Phoenix Infusion CatheterJXG · Traditional | 04/07/2004SE |
| K030468 | Acura Elite Gravity Compensating ReservoirJXG · Traditional | 10/15/2003SE |
| K024101 | Phoenix Universal Shunt SystemJXG · Special | 01/27/2003SE |
| K024040 | Accura Elite Shunt SystemJXG · Special | 01/27/2003SE |
| K021644 | Perf (Ommaya Style) ReservoirsJXG · Traditional | 08/06/2002SE |
| K002476 | Lumboperitoneal Shunt SystemJXG · Traditional | 11/09/2000SE |
| K000514 | Rumbar Drainage SystemJXG · Traditional | 05/10/2000SE |
| K991429 | Diamond II ValveJXG · Special | 05/19/1999SE |
| K990256 | CRX World ShuntJXG · Special | 04/01/1999SE |
| K974096 | CRX Diamond ValveJXG · Traditional | 12/08/1998SE |
Questions and answers
When was Suture Cord cleared by the FDA?
Suture Cord (K953128) received a 510(k) decision of Substantially Equivalent for Some Indications on February 9, 1996, 218 days after the submission was received.
What is the product code of K953128?
The FDA product code is GAS – Suture, Nonabsorbable, Synthetic, Polyester, a Class II (moderate risk) device regulated under 21 CFR 878.5000.