• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
New Search Back to Search Results
Device mesh, surgical, absorbable, fistula
Definition For reinforcement of soft tissue where weakness exists during the repair of fistulas.
Physical State An absorbable mesh; round, rectangular, square or of various other shapes
Technical Method An absorbable mesh for the reinforcement of soft tissue.
Target Area Anorectal, enterocutaneous, and recto-vaginal fistulas
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOXM
Premarket Review Infection Control and Plastic Surgery Devices (DHT4B)
Infection Control and Plastic Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 878.3300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible