Graft Guard
FDA 510(k) K885136 · Sorex Medical
510(k) numberK885136
Submission
- Device name
- Graft Guard
- Applicant
- Sorex Medical
Salt Lake City, UT, US - Received
- December 15, 1988
- Decision date
- February 6, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LZM – Guard, Skin Graft
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4014
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code LZM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K943871 | Aquaplast Tie Down DressingLZM · Traditional | Wfr/Aquaplast Corp. | 09/30/1994SE |
More from Wfr/Aquaplast Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K923843 | FoglessOCT · Traditional | 03/25/1994SE |
| K913036 | Plume MasterFYD · Traditional | 09/06/1991SE |
| K911070 | Picc-FixKMK · Traditional | 07/05/1991SE |
| K911150 | Sorex Safe-AirGEX · Traditional | 06/28/1991SE |
| K910315 | Picc Insertion Kit/P.I.C. & Picc Exchang Kit/P.E.KLJS · Traditional | 04/05/1991SEKD |
| K905572 | Edlich Wound Management TrayMCY · Traditional | 03/12/1991SEKD |
| K903740 | Trach-EzeBSY · Traditional | 12/06/1990SE |
| K902410 | Medical Procedure TrayLDQ · Traditional | 11/20/1990SEKD |
Questions and answers
When was Graft Guard cleared by the FDA?
Graft Guard (K885136) received a 510(k) decision of Substantially Equivalent on February 6, 1989, 53 days after the submission was received.
What is the product code of K885136?
The FDA product code is LZM – Guard, Skin Graft, a Class I (low risk) device regulated under 21 CFR 878.4014.