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510(k) K243152

GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device by Applied Medical Resources Corp. — Product Code HEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2025
Date Received
September 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culdoscope (And Accessories)
Device Class
Class II
Regulation Number
884.1640
Review Panel
OB
Submission Type

Other clearances by Applied Medical Resources Corp.

  • K252740 — Voyant® Open Fusion Device (EB240/Open Fusion) (November 4, 2025)
  • K252442 — Kii Structural Balloon Access System (October 31, 2025)
  • K200021 — Applied Medical Anoscope (January 6, 2021)
  • K201212 — Voyant Open Fusion Device (June 5, 2020)
  • K200598 — Voyant Maryland Fusion Device (April 8, 2020)
  • K193292 — Voyant 5mm Fusion Device, Voyant Maryland Fusion Device (December 20, 2019)
  • K191294 — Transvaginal Access Platform (September 6, 2019)
  • K182653 — Voyant Maryland Fusion Device (November 14, 2018)
  • K182244 — Voyant Electrosurgical Generator (October 11, 2018)
  • K182024 — Dissecting Balloon System (August 30, 2018)

Other clearances for product code HEW

  • K201086 — Advincula Delineator Uterine Manipulator (May 21, 2020)
  • K191294 — Transvaginal Access Platform (September 6, 2019)
  • K180429 — Advincula Delineator Uterine Manipulator (March 14, 2018)
  • K161065 — ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator (October 27, 2016)
  • K143308 — GelPOINT Transvaginal Access Platform (October 13, 2015)
  • K143650 — CooperSurgical Advincula Delineator Uterine Manipulator (July 21, 2015)
  • K111014 — LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES (July 13, 2012)
  • K110819 — SINGHMED ROOLIP MANIPULATOR (October 5, 2011)
  • K051594 — MCCARTNEY ACCESS TUBE (September 2, 2005)
  • K051160 — MANIPUSEAL (September 2, 2005)