Data / Medical devices / United Kingdom / Purple Surgical International Limited
Purple Surgical International Limited: FDA-registered device maker in Herts England, United Kingdom, 3 510(k) clearances
Purple Surgical International Limited is registered with the FDA (registration 3008439467) in Herts England, United Kingdom. It lists 14 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 21, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008439467
- Address
- 2 Chestnut House Farm Close, Shenley, Herts England, United Kingdom, WD7 9AD
- Owner or operator
- Purple Surgical International Limited (10033672)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- September 13, 2010
- Registered through
- 2026
- Brand names listed
- & Laparascopic Accessories, 5mm Laparoscopic Electrodes, Aspiration Needle (PS3895), Camera Sleeve - Various names and models, Endo Retrieval Pouches - Various names and models, Insufflation Filter Tubing Sets - Various names and models, Laparoscopic Blunt Tip Disector 5 x 41cm Single Use, Model Number: PS3852ULT and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 21, 2014 | K142868 | 5mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm Laparoscopic Electrode with Spatula, Monopolar cable with 4mm pin, Monopolar cable with 8mm pin | GEI | Substantially Equivalent | Purple Surgical International Limited | accessdata.fda.gov |
| February 6, 2009 | K081398 | ADVANCED MEDICAL INNOVATIONS DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES | GEI | Substantially Equivalent | Advanced Medical Innovations, Inc. | accessdata.fda.gov |
| October 25, 2002 | K022503 | UTERINE INJECTOR | LKF | Substantially Equivalent | Thomas Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Aspiration And Injection, Disposable
- All makers of Cannula, Manipulator/Injector, Uterine
- All makers of Bag, Intestine
- All makers of Curette, Surgical, General Use
- All makers of Tubing, Noninvasive
- All makers of Container, Specimen, Non-Sterile
Updated November 21, 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.