Identifiers
- 510(k) Number
- K954311 FDA 510(k)
- FDA Product Code
- HEW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.1640 FDA 510(k)
- Regulation Number
- 884.1640 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Koh Colpotomizer System is a culdoscope and accessories device used in obstetrics and gynecology. It is indicated for use in laparoscopic procedures where a uterine manipulator is appropriate and the surgeon intends to remove or access intraperitoneal tissue through the vagina via a colpotomy or culdotomy incision.
The system consists of the Koh Cup (vaginal fornices delineator) and Colpo-Pneumo Occluder, with accessories designed to attach to the RUMI uterine manipulator. It is supplied as a reusable system and has received FDA 510(k) clearance under K954311, classified as a Class II device under regulation number 884.1640.
Frequently asked questions
What is the Koh Colpotomizer System used for?
The Koh Colpotomizer System is indicated for use in laparoscopic procedures where a uterine manipulator is appropriate and the surgeon intends to remove or access intraperitoneal tissue through the vagina via a colpotomy or culdotomy incision, as it functions as a culdoscope and accessories device in obstetrics and gynecology.
Is the Koh Colpotomizer System reusable or single-use?
The Koh Colpotomizer System is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning and reprocessing, as stated in the device description.
What components are included in the Koh Colpotomizer System?
The system consists of the Koh Cup (vaginal fornices delineator) and Colpo-Pneumo Occluder, with accessories designed to attach to the RUMI uterine manipulator, forming a complete culdoscope and accessories setup for vaginal access during laparoscopic procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF 34145-IFU-C Model (1) - CooperSurgical, CooperSurgical Koh Colpotomizer Instructions For Use Manual, KOH COLPOTOMIZER SYSTEM (K954311) — FDA 510(k) | Innolitics, Coopersurgical Koh Colpotomizer Manuals | ManualsLib, PDF THE KOH COLPOTOMIZERTM SYSTEM - Medical Dynamics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K954311 | Class II | Active |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA 510(k) K954311 24 fields · synced Sep 21, 2026