HEW — Culdoscope (And Accessories) Class II
FDA Device Classification
Classification Details
- Product Code
- HEW
- Device Class
- Class II
- Regulation Number
- 884.1640
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K243152 | applied medical resources | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device | October 2, 2025 |
| K201086 | coopersurgical | Advincula Delineator Uterine Manipulator | May 21, 2020 |
| K191294 | applied medical resources | Transvaginal Access Platform | September 6, 2019 |
| K180429 | coopersurgical | Advincula Delineator Uterine Manipulator | March 14, 2018 |
| K161065 | surgitools pty | ColpoWave Colpotomizer and CerviGrip Uterine Manipulator | October 27, 2016 |
| K143308 | applied medical resources | GelPOINT Transvaginal Access Platform | October 13, 2015 |
| K143650 | coopersurgical | CooperSurgical Advincula Delineator Uterine Manipulator | July 21, 2015 |
| K111014 | lsi solutions | LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES | July 13, 2012 |
| K110819 | j.singh instruments | SINGHMED ROOLIP MANIPULATOR | October 5, 2011 |
| K051160 | insitu systems | MANIPUSEAL | September 2, 2005 |
| K051594 | gynetech pty. | MCCARTNEY ACCESS TUBE | September 2, 2005 |
| K033728 | karl storz endoscopy-america | TRANSVAGINAL ENDOSCOPY SET | February 27, 2004 |
| K992655 | soprane | FERTILOSCOPY KIT FH 1.29/FTO 1.40 | March 13, 2000 |
| K993804 | karl storz endoscopy-america | KSEA RIGID CULDOSCOPE AND ACCESSORIES | February 7, 2000 |
| K980972 | circon | RIGID CULDOSCOPE AND ACCESSORIES | June 12, 1998 |
| K964276 | richard wolf medical instruments | ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR | November 25, 1997 |
| K954311 | coopersurgical | KOH COLPOTOMIZER SYSTEM | November 19, 1996 |
| K962881 | karl storz endoscopy | KSEA CULDOCENTESIS SET | October 22, 1996 |