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510(k) K172545

SERI Contour by Sofregen Medical, Inc. — Product Code OXF

K172545 is an FDA 510(k) premarket notification submitted by Sofregen Medical, Inc. for the device "SERI Contour". The FDA issued a decision of Substantially Equivalent on September 22, 2017. The device falls under product code OXF (Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery), a Class II device regulated under 21 CFR 878.3300. Sofregen Medical, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2017
Date Received
August 23, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.

Other clearances by Sofregen Medical, Inc.

  • K240919 — Silk Voice (SMI-04) (May 3, 2024)
  • K180631 — Silk Voice (November 8, 2018)

Other clearances for product code OXF

  • K251224 — Restrata Soft Tissue Reinforcement (STR) (June 20, 2025)
  • K243302 — 3DMatrix DynaFlex (DynaFlex) (May 21, 2025)
  • K232602 — 3DMatrix Surgical Mesh (May 23, 2024)
  • K222919 — GORE® ENFORM Biomaterial (December 19, 2022)
  • K173333 — GORE ENFORM Biomaterial (April 5, 2018)
  • K163217 — GORE BIO-A Tissue Reinforcement (February 10, 2017)
  • K123128 — SERI SURGICAL SCAFFOLD (April 25, 2013)

FDA data resources