Syvek Patch
FDA 510(k) K972914 · Marine Polymer Technologies, Inc.
510(k) numberK972914
Submission
- Device name
- Syvek Patch
- Applicant
- Marine Polymer Technologies, Inc.
Danvers, MA, US - Received
- August 7, 1997
- Decision date
- December 22, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KGX – Tape And Bandage, Adhesive
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5240
- Specialty
- General Hospital
Other 510(k)s with product code KGX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K001240 | Seragard Injection PatchKGX · Traditional | Platinum Services, Inc. | 06/21/2000SE |
| K983368 | Care Band Antibacterial BandagesKGX · Traditional | Aso Corp. | 02/17/1999SE |
| K943314 | Adhesive Bandages with OTC DrugKGX · Traditional | Johnson & Johnson Consumer Products, Inc. | 01/17/1996SE |
| K952606 | Targett PatchKGX · Traditional | Cutting Edge Technologies, Inc. | 12/21/1995SE |
| K954007 | ParallelKGX · Traditional | Johnson & Johnson Consumer Products, Inc. | 11/22/1995SE |
| K944587 | Dermiview Hypoallergenic Clear TapeKGX · Traditional | Johnson & Johnson Medical, Inc. | 10/30/1995SE |
| K944588 | Sterile Plastic DressingKGX · Traditional | Smith & Nephew, Inc. | 11/07/1994SE |
| K941788 | Band-Aid Brand Adhesive Bandages, Sport StripKGX · Traditional | Johnson & Johnson Consumer Products, Inc. | 10/03/1994SE |
| K940536 | Band-Aid(Tm) Brand Adhesive BandageKGX · Traditional | Johnson & Johnson Consumer Products, Inc. | 10/03/1994SE |
| K940798 | Shippert Pressure BandageKGX · Traditional | Denver Splint Co. | 09/28/1994SE |
More from Denver Splint Co.
| 510(k) | Device | Decision |
|---|---|---|
| K160695 | Talymed SuspensionFRO · Traditional | 12/06/2016SE |
| K132293 | Syvek Radial BandDXC · Traditional | 07/31/2014SE |
| K111524 | MP 719MTJ · Traditional | 07/22/2011SE |
| K102002 | TalymedFRO · Traditional | 07/28/2010SE |
| K082703 | MRDH BandageKMF · Traditional | 10/14/2008SE |
| K070557 | MP 719FRO · Traditional | 05/23/2007SE |
| K053300 | SyvekexcelDXC · Traditional | 03/28/2006SE |
| K002550 | RDH BandageKMF · Traditional | 12/20/2000SE |
| K984177 | Modification to SkvekpatchKMF · Traditional | 12/18/1998SN |
Questions and answers
When was Syvek Patch cleared by the FDA?
Syvek Patch (K972914) received a 510(k) decision of Substantially Equivalent on December 22, 1997, 137 days after the submission was received.
What is the product code of K972914?
The FDA product code is KGX – Tape And Bandage, Adhesive, a Class I (low risk) device regulated under 21 CFR 880.5240.