Peter Lazic GmbH
TUTTLINGEN Baden-Wurttemberg, DE
PETER LAZIC GMBH appears in FDA device records in TUTTLINGEN Baden-Wurttemberg, DE. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Peter Lazic GmbH between 2008 and 2019. The busiest year on record is 2008, with 1. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2019 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8010890 | 3007264034 | PETER LAZIC GMBH | Immelmannweg 2, TUTTLINGEN Baden-Wurttemberg 78532 DE | 2026 | and 16 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HCIApplier, Aneurysm Clip
- GDOApplier, Surgical, Clip
- JOLCatheter And Tip, Suction
- KANChisel, Nasal
- HXDClamp
- HCHClip, Aneurysm
- FZSCurette, Surgical, General Use
- GDIDissector, Surgical, General & Plastic Surgery
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GEGElevator, Surgical, General & Plastic Surgery
- KAEForceps, Ent
- GENForceps, General & Plastic Surgery
- HYAForceps, Wire Holding
- GDZHandle, Scalpel
- KAGHolder, Speculum, Ent
- GDGHook, Surgical, General & Plastic Surgery
- GZXInstrument, Microsurgical
- EMFKnife, Surgical
- GFJMallet, Surgical, General & Plastic Surgery
- LRYPunch, Surgical
- GADRetractor
- HTXRongeur
- LRWScissors, General, Surgical
- GAFSpatula, Surgical, General & Plastic Surgery
- LRPTray, Surgical
- JZFTube, Ear Suction
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1279-2024 | D-Clip Standard/Mini Applier, 230mm 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. | Class II | Open, Classified | |
| Z-1278-2024 | D-Clip Standard/Mini Applier, 210mm 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. | Class II | Open, Classified | |
| Z-1277-2024 | 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. | Class II | Open, Classified | |
| Z-1288-2024 | L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile | Wrong product coloring. The paddle clips should be blank, but they are colored blue. | Class II | Open, Classified | |
| Z-1287-2024 | 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. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain