Data / Medical devices / United Kingdom / Algram Group Ltd
Algram Group Ltd: FDA-registered device maker in Plymouth Devon, United Kingdom, 3 510(k) clearances
Algram Group Ltd is registered with the FDA (registration 3007389669) in Plymouth Devon, United Kingdom. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 6, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007389669
- Address
- Eastern Wood Road Langage Industrial Estate, Plympton, Plymouth Devon, United Kingdom, PL7 5ET
- Owner or operator
- OLYMPUS CORPORATION (9067818)
- Roles
- Manufacturer
- First device listed
- February 23, 2016
- Registered through
- 2027
- Brand names listed
- A5961, A5976, A05951A, A05961A,WA05970A, WA05971A , WA05972A, WA05973A, WA05974A, WA05990A, WA05994A, WA05995A, MA-392, MA-474, MA-651, MAJ-1603, MAJ-1606, MAJ-1607, MAJ-1608 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Endoscopic Bite Block | MNK | 1 | Manufacturer | accessdata.fda.gov |
| Endoscopic Irrigation/Suction System | OCX | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Air, Non-Manual, For Endoscope | FEQ | 2 | Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Manufacturer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| April 6, 2020 | K193250 | Irrigation Tubing with CO2 or Air | OCX | Substantially Equivalent | Keymed (Medical and Industrial Equipment) , Ltd. | accessdata.fda.gov |
| September 13, 2010 | K100899 | OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 | FEQ | Substantially Equivalent | Keymed (Medical & Industrial Equipment), Ltd. | accessdata.fda.gov |
| August 2, 2004 | K033222 | OLYMPUS STERILIZATION TRAYS | KCT | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Endoscopic Bite Block
- All makers of Endoscopic Irrigation/Suction System
- All makers of Pump, Air, Non-Manual, For Endoscope
Updated April 6, 2020. 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.