CooperSurgical Advincula Delineator Uterine Manipulator
FDA 510(k) K143650 · CooperSurgical, Inc.
510(k) numberK143650
Submission
- Device name
- CooperSurgical Advincula Delineator Uterine Manipulator
- Applicant
- CooperSurgical, Inc.
Trumbull, CT, US - Received
- December 23, 2014
- Decision date
- July 21, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HEW – Culdoscope (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1640
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HEW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceHEW · Traditional | Applied Medical Resources Corp. | 10/02/2025SE |
| K201086 | Advincula Delineator Uterine ManipulatorHEW · Special | CooperSurgical, Inc. | 05/21/2020SE |
| K191294 | Transvaginal Access PlatformHEW · Traditional | Applied Medical Resources Corp. | 09/06/2019SE |
| K180429 | Advincula Delineator Uterine ManipulatorHEW · Special | CooperSurgical, Inc. | 03/14/2018SE |
| K161065 | ColpoWave Colpotomizer and CerviGrip Uterine ManipulatorHEW · Traditional | Surgitools Pty , Ltd. | 10/27/2016SE |
| K143308 | GelPOINT Transvaginal Access PlatformHEW · Traditional | Applied Medical Resources | 10/13/2015SE |
| K111014 | Lsi Solutions Fornisee System Uterine Manipulator and AccessoriesHEW · Traditional | Lsi Solutions, Inc. | 07/13/2012SE |
| K110819 | Singhmed Roolip ManipulatorHEW · Traditional | J.Singh Instruments | 10/05/2011SE |
| K051594 | Mccartney Access TubeHEW · Traditional | Gynetech Pty. , Ltd. | 09/02/2005SE |
| K051160 | ManipusealHEW · Traditional | Insitu Systems | 09/02/2005SE |
More from Insitu Systems
| 510(k) | Device | Decision |
|---|---|---|
| K261083 | Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum…MQG · Traditional | 08/19/2026SE |
| K243799 | Fetal PillowPWB · Traditional | 08/29/2025SE |
| K250438 | CooperSurgical Milex® PessariesHHW · Traditional | 04/11/2025SE |
| K223064 | ALLY II Uterine Positioning System (UPS)LKF · Special | 10/28/2022SE |
| K201086 | Advincula Delineator Uterine ManipulatorHEW · Special | 05/21/2020SE |
| K200038 | Endosee SystemHIH · Special | 02/05/2020SE |
| K191020 | G210 InviCell Plus with SignipHy pH monitoringPUB · Traditional | 01/14/2020SE |
| K191291 | Wallace Dual Lumen Oocyte Recovery SystemMQE · Special | 06/12/2019SE |
| K190639 | Endosee SystemHIH · Special | 05/15/2019SE |
| K182959 | Wallace Dual Lumen Oocyte Recovery SystemMQE · Traditional | 05/10/2019SE |
Questions and answers
When was CooperSurgical Advincula Delineator Uterine Manipulator cleared by the FDA?
CooperSurgical Advincula Delineator Uterine Manipulator (K143650) received a 510(k) decision of Substantially Equivalent on July 21, 2015, 210 days after the submission was received.
What is the product code of K143650?
The FDA product code is HEW – Culdoscope (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1640.