Data / Medical devices / Germany / Innovative Tomography Products GMBH
Innovative Tomography Products GMBH: FDA-registered device maker in Bochum North Rhine-Westphalia, Germany, 2 510(k) clearances
Innovative Tomography Products GMBH is registered with the FDA (registration 3014408997) in Bochum North Rhine-Westphalia, Germany. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 18, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014408997
- Address
- Universitaetsstrasse 136, Bochum North Rhine-Westphalia, Germany, 44799
- Owner or operator
- Innovative Tomography Products GmbH (10057613)
- Roles
- Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer, Specification developer
- First device listed
- May 2, 2018
- Registered through
- 2026
- Brand names listed
- Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM, Coaxial Interventional Needle KIM, Coaxial Interventional Needle KIR, KIM 15/36:90, KIM 20/20, KIM 25/03N, KIM13/04T, KIM13/09T and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Biopsy | KNW | 2 | Complaint file establishment, Foreign private label distributor, Manufacturer, Specification developer | accessdata.fda.gov |
| Marker, Skin | FZZ | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | 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 |
|---|---|---|---|---|---|---|
| June 18, 2024 | K233294 | Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM | KNW | Substantially Equivalent | Itp Innovative Tomography Products GmbH | accessdata.fda.gov |
| January 20, 2023 | K222462 | Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10) | KNW | Substantially Equivalent | Itp Innovative Tomography Products GmbH | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 21, 2021 | 88213 | Class II | Ongoing | Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIM 22/05, Length 50 mm, diameter 22G/0,7 mm; Article no. KIM 22/07,Length 75 mm, diameter 22 G (0.7 mm); | Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Aspiration And Injection, Disposable
- All makers of Instrument, Biopsy
- All makers of Marker, Skin
Updated June 18, 2024. 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.