CooperSurgical Advincula Delineator Uterine Manipulator
FDA 510(k) clearance K143650 · decided 2015-07-21
Clearance details
- K-number
- K143650
- Device name
- CooperSurgical Advincula Delineator Uterine Manipulator
- Applicant
- CooperSurgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-12-23
- Decision date
- 2015-07-21
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- HEW
- Device class
- 2
- Regulation number
- 884.1640
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Trumbull, CT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device (K243152) | Applied Medical Resources Corp. | 2025-10-02 |
| Advincula Delineator Uterine Manipulator (K201086) | CooperSurgical, Inc. | 2020-05-21 |
| Transvaginal Access Platform (K191294) | Applied Medical Resources Corp. | 2019-09-06 |
| Advincula Delineator Uterine Manipulator (K180429) | CooperSurgical, Inc. | 2018-03-14 |
| ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator (K161065) | Surgitools Pty , Ltd. | 2016-10-27 |
| GelPOINT Transvaginal Access Platform (K143308) | Applied Medical Resources | 2015-10-13 |
| LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES (K111014) | Lsi Solutions, Inc. | 2012-07-13 |
| SINGHMED ROOLIP MANIPULATOR (K110819) | J.Singh Instruments | 2011-10-05 |
| MANIPUSEAL (K051160) | Insitu Systems | 2005-09-02 |
| MCCARTNEY ACCESS TUBE (K051594) | Gynetech Pty. , Ltd. | 2005-09-02 |
| TRANSVAGINAL ENDOSCOPY SET (K033728) | KARL STORZ Endoscopy-America, Inc. | 2004-02-27 |
| FERTILOSCOPY KIT FH 1.29/FTO 1.40 (K992655) | Soprane S.A. | 2000-03-13 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Mara Water Vapor Ablation System (P160047/S039) | CooperSurgical, Inc. | 2025-01-07 |
| MARA Water Vapor Ablation System (P160047/S035) | CooperSurgical, Inc. | 2024-07-11 |
| MARA Water Vapor Ablation System (P160047/S038) | CooperSurgical, Inc. | 2024-07-09 |
| MARA Water Vapor Ablation System (P160047/S036) | CooperSurgical, Inc. | 2024-05-10 |
| Mater Water Vapor System - Model # GEA-SYS-16-0500, Mara Water Vapor Probe Kit - Model # DDK-16-050, Mara Console - Mode (P160047/S034) | CooperSurgical, Inc. | 2023-12-08 |
| MARA Water Vapor Ablation System (P160047/S033) | CooperSurgical, Inc. | 2023-10-25 |
| Mara Water Vapor Ablation System (P160047/S031) | CooperSurgical, Inc. | 2023-07-28 |
| Mara Water Vapor Ablation System (P160047/S032) | CooperSurgical, Inc. | 2023-07-27 |