Data / Medical devices / Instrument, Manual, Specialized Obstetric-Gynecologic
Instrument, Manual, Specialized Obstetric-Gynecologic (KNA): 17 FDA-registered makers in 6 countries
17 establishments in 6 countries are registered with the FDA to make Instrument, Manual, Specialized Obstetric-Gynecologic (product code KNA, Class 2, 21 CFR 884.4530). 6 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 58 510(k) clearances under this code, the latest on January 10, 2014, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KNA
- Device class
- 2
- Regulation
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Germany | 3 |
| Taiwan | 1 |
| China | 1 |
| Mexico | 1 |
| Pakistan | 1 |
Makers of Instrument, Manual, Specialized Obstetric-Gynecologic
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 |
|---|---|---|---|---|---|---|---|---|
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 4 | May 6, 2011 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 4 | May 6, 2011 | 0 | 0 | 0 | api.fda.gov |
| Coopersurgical, Inc. | Trumbull, CT, United States | Repackager or relabeler, Specification developer | 2 | March 22, 1989 | 0 | 0 | 0 | api.fda.gov |
| Bioteque Taiwan Ltd. | Xizhi Dist., New Taipei City, Taiwan | Exporter to the US, Manufacturer | 1 | January 10, 2014 | 0 | 0 | 0 | api.fda.gov |
| Kirwan Surgical Products, LLC. | Marshfield, MA, United States | Manufacturer | 1 | January 16, 1985 | 0 | 0 | 0 | api.fda.gov |
| Utah Medical Products, Inc. | Midvale, UT, United States | Manufacturer | 1 | December 21, 1995 | 0 | 0 | 0 | api.fda.gov |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allwin Medical Devices, Inc. | Anaheim, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Applied Medical Resources Corp. | Rsm, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Applied Medical Distribution Center | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aptyx - South Glens Falls | S Glens Falls, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gimmi GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebumedical GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu JianYu Health Medical Co., Ltd | Changzhou City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Martech Medical Products S. De RL. De CV. | MEXICALI Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qsa Surgical (pvt) Ltd. | SIALKOT Punjab, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 10, 2014. 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.