510(k) K180429
- Device
- Advincula Delineator Uterine Manipulator
- Applicant
- CooperSurgical, Inc.
- 510(k) number
- K180429
- Product code
- HEW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-03-14
- Date received
- 2018-02-16
- Regulation
- 884.1640
- Classification name
- Culdoscope (and Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Roaida Johnson
- Address
- 95 Corporate Dr. Trumbull CT US 06611 06611
FDA Registration Numbers
- 1627186
- 1320468
- 1418479
- 9611102
- 3012783431
- 3009763019
- 3003790304
- 3008693678
- 1519132
- 3007156625
- 2032098
- 1216677
- 2020550
- 8030607
- 3011050570
- 2246552
- 3010202439
- 2528981
- 2027111
- 3009051888
- 3008254127
- 1836161
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 20888937021374 | Advincula Delineator Uterine Manipulator | Coopersurgical, Inc. | 2018-08-13 |
| 20888937021367 | Advincula Delineator Uterine Manipulator | Coopersurgical, Inc. | 2018-08-13 |
| 20888937021350 | Advincula Delineator Uterine Manipulator | Coopersurgical, Inc. | 2018-08-13 |
| 20888937021343 | Advincula Delineator Uterine Manipulator | Coopersurgical, Inc. | 2018-08-13 |
Legacy Summary
summary
FDA Review
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