Spyroflex Wound Dressing
FDA 510(k) K953618 · Polymedica Industries, Inc.
510(k) numberK953618
Submission
- Device name
- Spyroflex Wound Dressing
- Applicant
- Polymedica Industries, Inc.
Golden,, CO, US - Received
- August 3, 1995
- Decision date
- August 21, 1995
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- MGP – Dressing, Wound And Burn, Occlusive
- Device class
- Unclassified
Other 510(k)s with product code MGP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K012997 | Collatek FoamMGP · Traditional | Biocore Medical Technologies, Inc. | 10/25/2001SE |
| K012995 | Collatek SheetMGP · Traditional | Biocore Medical Technologies, Inc. | 10/25/2001SE |
| K001508 | Laserskin DressingMGP · Traditional | Fidia Advanced Biopolymers Srl | 07/25/2001SE |
| K990079 | Fastseal Chest Wound DressingMGP · Traditional | Greenfield Medical Technologies, Inc. | 12/23/1999SE |
| K991214 | Simplicare Transparent Wound DressingMGP · Traditional | Hollister, Inc. | 10/14/1999SE |
| K992302 | Dermaphylyx Skin Protectors, Protect It Skin ProtectorsMGP · Traditional | Dermaphylyx, Inc. | 09/14/1999SE |
| K992005 | Giltech Plus Transparent DressingMGP · Traditional | Giltech Plus, Inc. | 09/03/1999SE |
| K990875 | Dermaphylyx Film Wound Dressing and Healian Film Wound DressingMGP · Traditional | Dermaphylyx, Inc. | 05/27/1999SN |
| K990438 | Dermaflex Wound Dressing, Dermaflex Foam Wound Dressing, Healiaflex Wound Dressing…MGP · Traditional | Dermaphylyx, Inc. | 03/25/1999SE |
| K984371 | Mepitel Non Adherent Silicone DressingMGP · Traditional | Molnlycke Health Care, Inc. | 03/03/1999SE |
More from Molnlycke Health Care, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K964398 | Spyroflex Pigmented Wound Dressing/Spyroflex Wound Dressing TintedMGP · Traditional | 10/24/1997SE |
| K971045 | Basis Flexible Tip Digital ThermometerFLL · Traditional | 05/02/1997SE |
| K964701 | Mitraflex Pigmented Wound DressingFRO · Traditional | 02/07/1997SE |
| K963623 | Spyroflex Pigmented Wound DressingMGP · Traditional | 10/25/1996SE |
| K962991 | Basis Baby-Temp Pacifier Digital TherometerFLL · Traditional | 09/12/1996SE |
| K955383 | Spyrocolloid Wound DressingMGP · Traditional | 12/13/1995SN |
| K953885 | Spyroflex Skin ProtectorMGP · Traditional | 11/29/1995SE |
| K952756 | Medi-Aid Basal ThermometerLHD · Traditional | 09/25/1995SE |
| K952159 | Basis Digital ThermometerFLL · Traditional | 09/22/1995SE |
| K951862 | A Gel Wound DressingMGQ · Traditional | 07/12/1995SE |
Questions and answers
When was Spyroflex Wound Dressing cleared by the FDA?
Spyroflex Wound Dressing (K953618) received a 510(k) decision of Substantially Equivalent for Some Indications on August 21, 1995, 18 days after the submission was received.
What is the product code of K953618?
The FDA product code is MGP – Dressing, Wound And Burn, Occlusive, a Unclassified device.