FDA Product Code
FDA Product Code HEW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.1640
510(k) Clearances — 18 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device | Applied Medical Resources Corp. | 2025-10-02 | Traditional | PDF ↗ |
| K201086 | Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | 2020-05-21 | Special | PDF ↗ |
| K191294 | Transvaginal Access Platform | Applied Medical Resources Corp. | 2019-09-06 | Traditional | PDF ↗ |
| K180429 | Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | 2018-03-14 | Special | PDF ↗ |
| K161065 | ColpoWave Colpotomizer and CerviGrip Uterine Manipulator | Surgitools Pty , Ltd. | 2016-10-27 | Traditional | PDF ↗ |
| K143308 | GelPOINT Transvaginal Access Platform | Applied Medical Resources | 2015-10-13 | Traditional | PDF ↗ |
| K143650 | CooperSurgical Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | 2015-07-21 | Traditional | PDF ↗ |
| K111014 | LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES | Lsi Solutions, Inc. | 2012-07-13 | Traditional | PDF ↗ |
| K110819 | SINGHMED ROOLIP MANIPULATOR | J.Singh Instruments | 2011-10-05 | Traditional | PDF ↗ |
| K051594 | MCCARTNEY ACCESS TUBE | Gynetech Pty. , Ltd. | 2005-09-02 | Traditional | PDF ↗ |
| K051160 | MANIPUSEAL | Insitu Systems | 2005-09-02 | Traditional | PDF ↗ |
| K033728 | TRANSVAGINAL ENDOSCOPY SET | KARL STORZ Endoscopy-America, Inc. | 2004-02-27 | Traditional | PDF ↗ |
| K992655 | FERTILOSCOPY KIT FH 1.29/FTO 1.40 | Soprane S.A. | 2000-03-13 | Traditional | PDF ↗ |
| K993804 | KSEA RIGID CULDOSCOPE AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | 2000-02-07 | Traditional | PDF ↗ |
| K980972 | RIGID CULDOSCOPE AND ACCESSORIES | Circon Corp. | 1998-06-12 | Traditional | PDF ↗ |
| K964276 | ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR | Richard Wolf Medical Instruments Corp. | 1997-11-25 | Traditional | PDF ↗ |
| K954311 | KOH COLPOTOMIZER SYSTEM | CooperSurgical, Inc. | 1996-11-19 | Traditional | PDF ↗ |
| K962881 | KSEA CULDOCENTESIS SET | Karl Storz Endoscopy | 1996-10-22 | Traditional | PDF ↗ |
Product code HEW · Class II · Obstetrics/Gynecology. Data: openFDA.