HEW · Culdoscope (And Accessories)
Obstetrics/Gynecology · 21 CFR 884.1640 · Class 2
Overview
| Product Code | HEW |
|---|---|
| Device Name | Culdoscope (And Accessories) |
| Regulation | 21 CFR 884.1640 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
Identification
A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include trocar and cannula, instruments used through an operating channel, scope preheaters, light source and cables, and component parts.
Classification Rationale
(1) Class II (performance standards). (2) Class I for culdoscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources.
Recent Cleared Devices (18 of 18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device | Applied Medical Resources Corp. | Oct 2, 2025 | SESE |
| K201086 | Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | May 21, 2020 | SESE |
| K191294 | Transvaginal Access Platform | Applied Medical Resources Corp. | Sep 6, 2019 | SESE |
| K180429 | Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | Mar 14, 2018 | SESE |
| K161065 | ColpoWave Colpotomizer and CerviGrip Uterine Manipulator | Surgitools Pty , Ltd. | Oct 27, 2016 | SESE |
| K143308 | GelPOINT Transvaginal Access Platform | Applied Medical Resources | Oct 13, 2015 | SESE |
| K143650 | CooperSurgical Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | Jul 21, 2015 | SESE |
| K111014 | LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES | Lsi Solutions, Inc. | Jul 13, 2012 | SESE |
| K110819 | SINGHMED ROOLIP MANIPULATOR | J.Singh Instruments | Oct 5, 2011 | SESE |
| K051594 | MCCARTNEY ACCESS TUBE | Gynetech Pty. , Ltd. | Sep 2, 2005 | SESE |
| K051160 | MANIPUSEAL | Insitu Systems | Sep 2, 2005 | SESE |
| K033728 | TRANSVAGINAL ENDOSCOPY SET | KARL STORZ Endoscopy-America, Inc. | Feb 27, 2004 | SESE |
| K992655 | FERTILOSCOPY KIT FH 1.29/FTO 1.40 | Soprane S.A. | Mar 13, 2000 | SESE |
| K993804 | KSEA RIGID CULDOSCOPE AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | Feb 7, 2000 | SESE |
| K980972 | RIGID CULDOSCOPE AND ACCESSORIES | Circon Corp. | Jun 12, 1998 | SESE |
| K964276 | ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR | Richard Wolf Medical Instruments Corp. | Nov 25, 1997 | SESE |
| K954311 | KOH COLPOTOMIZER SYSTEM | CooperSurgical, Inc. | Nov 19, 1996 | SESE |
| K962881 | KSEA CULDOCENTESIS SET | Karl Storz Endoscopy | Oct 22, 1996 | SESE |
Top Applicants
- CooperSurgical, Inc. — 4 clearances
- Applied Medical Resources Corp. — 2 clearances
- KARL STORZ Endoscopy-America, Inc. — 2 clearances
- Applied Medical Resources — 1 clearance
- Circon Corp. — 1 clearance
