Product code HEW
- Device name
- Culdoscope (And Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.1640
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device | Applied Medical Resources Corp. | 2025-10-02 |
| K201086 | Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | 2020-05-21 |
| K191294 | Transvaginal Access Platform | Applied Medical Resources Corp. | 2019-09-06 |
| K180429 | Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | 2018-03-14 |
| K161065 | ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator | Surgitools Pty , Ltd. | 2016-10-27 |
| K143308 | GelPOINT Transvaginal Access Platform | Applied Medical Resources | 2015-10-13 |
| K143650 | CooperSurgical Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | 2015-07-21 |
| K111014 | LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES | Lsi Solutions, Inc. | 2012-07-13 |
| K110819 | SINGHMED ROOLIP MANIPULATOR | J.Singh Instruments | 2011-10-05 |
| K051160 | MANIPUSEAL | Insitu Systems | 2005-09-02 |
| K051594 | MCCARTNEY ACCESS TUBE | Gynetech Pty. , Ltd. | 2005-09-02 |
| K033728 | TRANSVAGINAL ENDOSCOPY SET | KARL STORZ Endoscopy-America, Inc. | 2004-02-27 |
| K992655 | FERTILOSCOPY KIT FH 1.29/FTO 1.40 | Soprane S.A. | 2000-03-13 |
| K993804 | KSEA RIGID CULDOSCOPE AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | 2000-02-07 |
| K980972 | RIGID CULDOSCOPE AND ACCESSORIES | Circon Corp. | 1998-06-12 |
| K964276 | ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR | Richard Wolf Medical Instruments Corp. | 1997-11-25 |
| K954311 | KOH COLPOTOMIZER SYSTEM | CooperSurgical, Inc. | 1996-11-19 |
| K962881 | KSEA CULDOCENTESIS SET | Karl Storz Endoscopy | 1996-10-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10607915147812 | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device | APPLIED MEDICAL RESOURCES CORPORATION | 2026-04-22 |
| 19349967005009 | ColpotomizOR Tube System | THE O R COMPANY PTY LTD | 2023-04-04 |
| 19349967004996 | ColpotomizOR Tube System | THE O R COMPANY PTY LTD | 2023-04-04 |
| 00607915138493 | GelPOINT V-Path | APPLIED MEDICAL RESOURCES CORPORATION | 2019-09-17 |
| 00607915138486 | GelPOINT V-Path | APPLIED MEDICAL RESOURCES CORPORATION | 2019-09-17 |
| 00607915138660 | GelPOINT V-Path | APPLIED MEDICAL RESOURCES CORPORATION | 2019-09-17 |
| 09349967003442 | ColpotomizOR Tube System | THE O R COMPANY PTY LTD | 2019-03-27 |
| 09349967003473 | ColpotomizOR Tube System | THE O R COMPANY PTY LTD | 2019-03-27 |
| 09349967002728 | LiNA McCartney Tube | THE O R COMPANY PTY LTD | 2019-03-27 |
| 09349967002698 | LiNA McCartney Tube | THE O R COMPANY PTY LTD | 2019-03-27 |
| 09349967002605 | ColpotomizOR Tube | THE O R COMPANY PTY LTD | 2019-03-27 |
| 09349967002575 | ColpotomizOR Tube | THE O R COMPANY PTY LTD | 2019-03-27 |
| 09349967002544 | McCartney Tube | THE O R COMPANY PTY LTD | 2019-03-27 |
| 09349967002513 | McCartney Tube | THE O R COMPANY PTY LTD | 2019-03-27 |
| 09351599000119 | ColpoWave Balloon | SURGITOOLS PTY. LTD. | 2017-12-08 |
| 09351599000126 | ColpoWave Balloon | SURGITOOLS PTY. LTD. | 2017-12-08 |
| 09351599000218 | CerviGrip Uterine Manipulator | SURGITOOLS PTY. LTD. | 2017-12-08 |
| 09351599000225 | CerviGrip Uterine Manipulator | SURGITOOLS PTY. LTD. | 2017-12-08 |
| 09351599000317 | ColpoWave Colpotomizer | SURGITOOLS PTY. LTD. | 2017-12-08 |
| 09351599000324 | ColpoWave Colpotomizer | SURGITOOLS PTY. LTD. | 2017-12-08 |
| 09349967001455 | ColpotomizOR Tube | THE O R COMPANY PTY LTD | 2017-11-16 |
| 09349967001424 | ColpotomizOR Tube | THE O R COMPANY PTY LTD | 2017-11-16 |
| 00888937012774 | Advincula Delineator™ Uterine Manipulator with 3.0 cm Stainless Steel Koh-Effici | Coopersurgical, Inc. | 2016-09-23 |
| 00888937012743 | Advincula Delineator™ Uterine Manipulator with 3.0 cm Ultem® Koh-Efficient® | Coopersurgical, Inc. | 2016-09-23 |
| 00888937012767 | Advincula Delineator™ Uterine Manipulator with 4.0 cm Ultem® Koh-Efficient® | Coopersurgical, Inc. | 2016-09-23 |
| 09349967000335 | ColpotomizOR Tube System | SURGI SUPPLIES INTERNATIONAL PTY. LTD. | 2016-09-22 |
| 09349967000304 | ColpotomizOR Tube System | SURGI SUPPLIES INTERNATIONAL PTY. LTD. | 2016-09-22 |
| 09349967000274 | ColpotomizOR Tube | SURGI SUPPLIES INTERNATIONAL PTY. LTD. | 2016-09-22 |
| 09349967000243 | ColpotomizOR Tube | SURGI SUPPLIES INTERNATIONAL PTY. LTD. | 2016-09-22 |
| 00888937012750 | Advincula Delineator™ Uterine Manipulator with 3.5 cm Ultem® Koh-Efficient® | Coopersurgical, Inc. | 2016-09-20 |