K162922 is an FDA 510(k) clearance for the GalaFORM 3D. This device is classified as a Surgical Film (Class II - Special Controls, product code OOD).
Submitted by Tepha, Inc. (Lexington, US). The FDA issued a Cleared decision on February 23, 2017, 128 days after receiving the submission on October 18, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300. To Be Implanted To Reinforce Soft Tissue Or Bone Where Weakness Exists. Intended To Be Used Wherever Temporary Wound Support Is Required, To Reinforce Soft Tissues Where Weakness Exists In The Urological, Gynecological, Or Gastrointestinal Anatomy, Or For The Repair Of Hernia Or Other Fascial Defects That Require The Addition Of A Reinforcing Or Bridging Material To Obtain The Desired Surgical Result. The Absorbable Protective Film Also May Help Minimize The Potential For Tissue Attachment To The Device In Case Of Direct Contact With The Viscera..
| 510(k) Number | K162922 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 2016 |
| Decision Date | February 23, 2017 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OOD - Surgical Film |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | To Be Implanted To Reinforce Soft Tissue Or Bone Where Weakness Exists. Intended To Be Used Wherever Temporary Wound Support Is Required, To Reinforce Soft Tissues Where Weakness Exists In The Urological, Gynecological, Or Gastrointestinal Anatomy, Or For The Repair Of Hernia Or Other Fascial Defects That Require The Addition Of A Reinforcing Or Bridging Material To Obtain The Desired Surgical Result. The Absorbable Protective Film Also May Help Minimize The Potential For Tissue Attachment To The Device In Case Of Direct Contact With The Viscera. |