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510(k) K122459

PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM by Boston Scientific Corporation — Product Code OTP

K122459 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM". The FDA issued a decision of Substantially Equivalent on December 13, 2012. The device falls under product code OTP (Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed), a Class III device regulated under 21 CFR 884.5980. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2012
Date Received
August 13, 2012
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Device Class
Class III
Regulation Number
884.5980
Review Panel
OB
Submission Type

Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; Procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical or uterine prolapse repair performed transvaginally

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  • K260100 — MOSES Raydar™ (May 18, 2026)
  • K260771 — TruSelect™ 2.6 Microcatheter (May 15, 2026)
  • K251273 — Asurys Fluid Management System (March 27, 2026)
  • K260479 — TheraSphere 360™ Y-90 Management Platform (March 13, 2026)
  • K260119 — SpaceOAR Vue System (SV-2101) (February 10, 2026)
  • K252529 — Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M00681 (October 30, 2025)
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  • K252547 — TheraSphere 360™ Y-90 Management Platform (October 28, 2025)

Other clearances for product code OTP

  • K121612 — ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION (July 20, 2012)
  • K112842 — AMS ELEVATE PC (October 25, 2011)
  • K103426 — LITE PELVIC FLOOR REPAIR KITS (September 14, 2011)
  • K112386 — EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM (September 8, 2011)
  • K102815 — SURELIFT PROLAPSE SYSTEM (July 7, 2011)
  • K111118 — AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR S (July 1, 2011)
  • K092207 — RESTORELLE POLYPROPYLENE MESH (August 4, 2009)
  • K091131 — PELVIC FLOOR REPAIR SYSTEM (May 8, 2009)
  • K083499 — EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS (May 8, 2009)
  • K090713 — ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR (April 2, 2009)

FDA data resources