Data / Medical devices / Culdoscope (And Accessories)
Culdoscope (And Accessories) (HEW): 13 FDA-registered makers in 5 countries
13 establishments in 5 countries are registered with the FDA to make Culdoscope (And Accessories) (product code HEW, Class 2, 21 CFR 884.1640). 8 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 18 510(k) clearances under this code, the latest on October 2, 2025, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HEW
- Device class
- 2
- Regulation
- 884.1640
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Germany | 1 |
| Australia | 1 |
| Mexico | 1 |
| China | 1 |
Makers of Culdoscope (And Accessories)
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Coopersurgical, Inc. | Trumbull, CT, United States | Manufacturer, Specification developer | 4 | May 21, 2020 | 0 | 3 | 0 | api.fda.gov |
| Applied Medical Resources Corp. | Rsm, CA, United States | Complaint file establishment, Manufacturer | 2 | October 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Applied Medical Distribution Center | Irvine, CA, United States | Manufacturer | 2 | October 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 1 | September 2, 2005 | 0 | 0 | 0 | api.fda.gov |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Specification developer | 1 | June 12, 1998 | 0 | 0 | 0 | api.fda.gov |
| Lsi Solutions Inc. | Victor, NY, United States | Manufacturer | 1 | July 13, 2012 | 0 | 0 | 0 | api.fda.gov |
| Richard Wolf GMBH | KNITTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 1 | November 25, 1997 | 0 | 0 | 0 | api.fda.gov |
| The O R Company Pty Ltd | Cheltenham Victoria, Australia | Exporter to the US, Foreign private label distributor, Specification developer | 1 | September 2, 2005 | 0 | 0 | 0 | api.fda.gov |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lone Star Medical Products | Stafford, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nissha Medical Technologies (Ohio), Inc. | Norwalk, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard Wolf Medical Instruments Corp. | Vernon Hills, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tonglu Qianyan Medtech Co.,ltd | hangzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 2, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.