Polyviolene(Tm) Suture
FDA 510(k) K904054 · Look, Inc.
510(k) numberK904054
Submission
- Device name
- Polyviolene(Tm) Suture
- Applicant
- Look, Inc.
Ada, OK, US - Received
- July 31, 1990
- Decision date
- October 3, 1990
- Decision
- Substantially Equivalent (SESE)
- 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 |
| K953128 | Suture CordGAS · Traditional | Phoenix Biomedical Corp. | 02/09/1996SN |
| 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 |
More from Advance Suture, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K943949 | Polyviolene Surgicl SutureGAT · Traditional | 11/10/1994SN |
| K933686 | Look Inc. 316L Stainless Steel Surgical SutureGAQ · Traditional | 12/23/1993SE |
| K926586 | Revised Labeling for Chromic and Plain Gut SuturesGAL · Traditional | 12/22/1993SE |
| K926588 | Revised Labeling for Polypropylene SutureGAW · Traditional | 12/17/1993SE |
| K926587 | Revised Labeling for Nylon Suture (Polyamide)GAR · Traditional | 12/17/1993SE |
| K926168 | Silk Sutures-Revised LabelingGAR · Traditional | 12/17/1993SE |
| K926167 | Polyviolene Suture-Revised LabelingGAT · Traditional | 12/17/1993SE |
| K913530 | Look ViscodissectorHQC · Traditional | 10/21/1991SE |
| K903029 | Sterile Black Monofilament Nylon Non-Absor. SutureGAR · Traditional | 10/25/1990SE |
| K903584 | Polypropylene Nonabsorbable Surgical SuturesGAW · Traditional | 10/11/1990SE |
Questions and answers
When was Polyviolene(Tm) Suture cleared by the FDA?
Polyviolene(Tm) Suture (K904054) received a 510(k) decision of Substantially Equivalent on October 3, 1990, 64 days after the submission was received.
What is the product code of K904054?
The FDA product code is GAS – Suture, Nonabsorbable, Synthetic, Polyester, a Class II (moderate risk) device regulated under 21 CFR 878.5000.