Data / Medical devices / Germany / Peter Lazic GMBH
Peter Lazic GMBH: FDA-registered device maker in TUTTLINGEN Baden-Wurttemberg, Germany, 3 510(k) clearances
Peter Lazic GMBH is registered with the FDA (registration 8010890) in TUTTLINGEN Baden-Wurttemberg, Germany. It lists 26 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 12, 2019. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8010890
- FEI number
- 3007264034
- Address
- Immelmannweg 2, TUTTLINGEN Baden-Wurttemberg, Germany, 78532
- Owner or operator
- PETER LAZIC GMBH (8010890)
- Roles
- Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- March 25, 2009
- Registered through
- 2027
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 |
|---|---|---|---|---|---|---|
| April 12, 2019 | K180757 | D-Clip; D-Clip Applier | HCH | Substantially Equivalent | Peter Lazic GmbH | accessdata.fda.gov |
| June 21, 2010 | K101080 | NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXX | GEI | Substantially Equivalent | Egon Faulhaber Surgical Instruments Pinzetten | accessdata.fda.gov |
| September 25, 2008 | K081489 | L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS | HCH | Substantially Equivalent | Peter Lazic 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 |
|---|---|---|---|---|---|---|
| October 6, 2023 | 93938 | Class II | Ongoing | D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action. | Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip. | accessdata.fda.gov |
| July 14, 2023 | 93952 | Class II | Ongoing | L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Sterile | Wrong product coloring. The paddle clips should be blank, but they are colored blue. | accessdata.fda.gov |
Compare with other makers
- All makers of Hook, Surgical, General & Plastic Surgery
- All makers of Forceps, Wire Holding
- All makers of Clamp
- All makers of Knife, Surgical
- All makers of Clip, Aneurysm
- All makers of Applier, Aneurysm Clip
Updated March 11, 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.