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510(k) K101722

ALYTE Y-MESH GRAFT by C.R. Bard, Inc. — Product Code OTO

K101722 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "ALYTE Y-MESH GRAFT". The FDA issued a decision of Substantially Equivalent on April 1, 2011. The device falls under product code OTO (Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed), a Class II device regulated under 21 CFR 878.3300. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2011
Date Received
June 18, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Device Class
Class II
Regulation Number
878.3300
Review Panel
OB
Submission Type

Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.

Other clearances by C.R. Bard, Inc.

  • K253514 — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blake (July 10, 2026)
  • K254076 — BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit (May 29, 2026)
  • K252971 — Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (La (March 17, 2026)
  • K251864 — Rubber Utility Catheter (February 23, 2026)
  • K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) (May 15, 2025)
  • K241334 — Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Elec (January 31, 2025)
  • K230356 — Aspirex™ Thrombectomy System (March 31, 2023)
  • K223177 — Highlander™ 014 PTA Balloon Dilatation Catheter (January 20, 2023)
  • K222793 — WavelinQ™ Generator (October 17, 2022)
  • K220270 — Aspirex Thrombectomy System (June 21, 2022)

Other clearances for product code OTO

  • K171271 — Polyform Synthetic Mesh (December 15, 2017)
  • K150016 — Vertessa Lite (April 6, 2015)
  • K150023 — Vertessa Lite Y-Mesh (April 6, 2015)
  • K140116 — RESTORELLE Y CONTOUR MESH (February 12, 2014)
  • K132061 — RESTORELLE M, RESTORELLE XL (August 2, 2013)
  • K123028 — VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH (April 25, 2013)
  • K123914 — RESTORELLE Y CONTOUR (March 5, 2013)
  • K123337 — VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM (February 21, 2013)
  • K122968 — NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 (December 18, 2012)
  • K122794 — UPSYLON Y MESH (December 18, 2012)

FDA data resources