Data / Medical devices / Germany / XION GmbH
XION GmbH: FDA-registered device maker in Berlin, Germany, 5 510(k) clearances
XION GmbH is registered with the FDA (registration 9515015) in Berlin, Germany. It lists 7 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 7, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9515015
- FEI number
- 3003276727
- Address
- Pankstrasse 8, Berlin, Germany, 13127
- Owner or operator
- HENKE-SASS WOLF, GMBH. (8010418)
- Roles
- Repackager or relabeler
- First device listed
- July 7, 1998
- Registered through
- 2026
- Brand names listed
- 1.9MM OBTURATOR, 1.9MM SPEEDLOCK PENCIL TIP OBTURATOR, 1.9MM TROCAR, 2.3MM OBTURATOR, 2.3MM AUTOCLAVABLE BLUNT TIP OBTURATOR WITH SPEED-LOCK, 2.3MM AUTOCLAVABLE PENCIL TIP OBTURATOR WITH SPEED-LOCK, 2.3MM AUTOCLAVABLE TROCAR FOR 2.9MM CANNULA WITH SPEED-LOCK, 2.3MM TROCAR and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Arthroscopic | NBH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Arthroscope | HRX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Hysteroscope (And Accessories) | HIH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | 2 | Repackager or relabeler | accessdata.fda.gov |
| Otoscope | ERA | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| December 7, 2017 | K171336 | Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath | FAJ | Substantially Equivalent | Henke-Sass, Wolf GmbH | accessdata.fda.gov |
| March 18, 2008 | K080560 | HENKE SASS WOLF OF AMERICA ARTHROSCOPE | HRX | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
| March 24, 2005 | K050163 | HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE | GCJ | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
| August 13, 1998 | K981751 | SINUSCOPE AND ACCESSORIES | EOB | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
| May 16, 1994 | K941541 | HSV LAPAROSCOPY SET | GCJ | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Otoscope
- All makers of Arthroscope
- All makers of Hysteroscope (And Accessories)
- All makers of Cystoscope And Accessories, Flexible/Rigid
- All makers of Nasopharyngoscope (Flexible Or Rigid)
Updated December 7, 2017. 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.