Panels › Obstetrics/Gynecology › Product code HEW · Class 2
Culdoscope (And Accessories)
Regulation 884.1640
0510(k)s in 12 months (18 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in HEW
| Company | 510(k)s | Recalls |
|---|---|---|
| CooperSurgical, Inc. | 4 | 4 |
| Applied Medical Resources | 3 | 0 |
| KARL STORZ Endoscopy-America, Inc. | 2 | 0 |
| Circon Corp. | 1 | 0 |
| Gynetech Pty. , Ltd. | 1 | 0 |
| Insitu Systems | 1 | 0 |
| J.Singh Instruments | 1 | 0 |
| Karl Storz Endoscopy | 1 | 0 |
| Lsi Solutions, Inc. | 1 | 0 |
| Richard Wolf Medical Instruments Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2021 | CooperSurgical, Inc. The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex.
Model Number(s): KCP-30-2 Open, Classified |
HEW | K954311 |
| Jun 14, 2019 | CooperSurgical, Inc. Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm; Part No. AD750SC-KE30
The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Lapa Terminated |
HEW | K180429 |
| Jun 14, 2019 | CooperSurgical, Inc. Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25
The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Lapa Terminated |
HEW | K180429 |
| Sep 4, 2018 | CooperSurgical, Inc. Colpo-Pneumo Occluder, Part CPO-6 Terminated |
HEW | K954311 |
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