Home / 510(k) Clearances / K051160

510(k) K051160

MANIPUSEAL by Insitu Systems — Product Code HEW

K051160 is an FDA 510(k) premarket notification submitted by Insitu Systems for the device "MANIPUSEAL". The FDA issued a decision of Substantially Equivalent on September 2, 2005. The device falls under product code HEW (Culdoscope (And Accessories)), a Class II device regulated under 21 CFR 884.1640.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2005
Date Received
May 5, 2005
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 for product code HEW

  • K243152 — GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device (October 2, 2025)
  • 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)

FDA data resources