K091633 is an FDA 510(k) clearance for the TEPHAFLEX SURGICAL FILM. 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 August 7, 2009, 64 days after receiving the submission on June 4, 2009.
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 | K091633 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2009 |
| Decision Date | August 07, 2009 |
| Days to Decision | 64 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. |