Culdoscope (And Accessories)
FDA product code HEW · Class II (moderate risk) · 21 CFR 884.1640 · Obstetrics/Gynecology
18510(k) clearances
0PMA approvals
4recalls
Manufacturers
510(k) clearances
| 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 |
| K143650 | CooperSurgical Advincula Delineator Uterine ManipulatorHEW · Traditional | CooperSurgical, Inc. | 07/21/2015SE |
| 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 |
| K033728 | Transvaginal Endoscopy SetHEW · Traditional | KARL STORZ Endoscopy-America, Inc. | 02/27/2004SE |
| K992655 | Fertiloscopy Kit FH 1.29/FTO 1.40HEW · Traditional | Soprane S.A. | 03/13/2000SE |
| K993804 | Ksea Rigid Culdoscope and AccessoriesHEW · Traditional | KARL STORZ Endoscopy-America, Inc. | 02/07/2000SE |
| K980972 | Rigid Culdoscope and AccessoriesHEW · Traditional | Circon Corp. | 06/12/1998SE |
| K964276 | Endoscopic Hysterectomy and Uterus ManipulatorHEW · Traditional | Richard Wolf Medical Instruments Corp. | 11/25/1997SE |
| K954311 | Koh Colpotomizer SystemHEW · Traditional | CooperSurgical, Inc. | 11/19/1996SE |
| K962881 | Ksea Culdocentesis SetHEW · Traditional | Karl Storz Endoscopy | 10/22/1996SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1686-2021 Class II | The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices…The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm… | CooperSurgical, Inc. | 04/23/2021Open, Classified |
| Z-1978-2019 Class II | Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm; Part No. AD750SC-KE30 The…The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when… | CooperSurgical, Inc. | 06/14/2019Terminated |
| Z-1977-2019 Class II | Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The…The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when… | CooperSurgical, Inc. | 06/14/2019Terminated |
| Z-0098-2019 Class II | Colpo-Pneumo Occluder, Part CPO-6The seal of the sterile pouch may be compromised, thereby increasing the risk of infection. | CooperSurgical, Inc. | 09/04/2018Terminated |