Home / 510(k) Clearances / K052953

510(k) K052953

NUVANCE* FACIAL REJUVENATION SYSTEM by Ethicon, Inc. — Product Code MXW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2006
Date Received
October 20, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)
Device Class
Class II
Regulation Number
878.5010
Review Panel
SU
Submission Type

Other clearances by Ethicon, Inc.

  • K253852 — MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthet (February 6, 2026)
  • K252743 — STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MO (December 22, 2025)
  • K243897 — PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Su (November 12, 2025)
  • K221744 — STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (November 15, 2022)
  • K212380 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Sutu (February 22, 2022)
  • K213512 — DERMABOND PRINEO Skin Closure System (December 7, 2021)
  • K201996 — Monocryl Plus Antibacterial Suture (December 21, 2020)
  • K201686 — GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ (September 17, 2020)
  • K201143 — VICRYL Mesh (August 6, 2020)
  • K192144 — STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device (March 25, 2020)

Other clearances for product code MXW

  • K060465 — PREMIO (January 17, 2007)