Karl Storz Endoskop GmbH
Culver City, CA, US
Karl Storz Endoskop GmbH appears in FDA device records in Culver City, CA. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Karl Storz Endoskop GmbH between 1994 and 1997. The busiest year on record is 1994, with 5. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 5 |
| 1995 | 4 |
| 1996 | 1 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K973068 | KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING | GCJ | Substantially Equivalent | |
| K961702 | KSEA VAPORIZATION ELECTRODES | FAS | Substantially Equivalent | |
| K953368 | LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES | BTR | Substantially Equivalent | |
| K943713 | TORCARS,CANNULAE,SHEATHS,OBTURATORS | HET | Substantially Equivalent | |
| K951995 | KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR | KNY | Substantially Equivalent | |
| K943053 | KSEA SEMM TISSUR PUNCH | HET | Substantially Equivalent | |
| K943435 | CHOLANGIOGRAPHY SET | GCJ | Substantially Equivalent | |
| K944823 | KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES, INSERT TUBES | GEI | Substantially Equivalent | |
| K943904 | RIGID TELESCOPES | ENZ | Substantially Equivalent | |
| K943697 | TROCARS,CANNULAE,SHEATHS,OBTURATORS | ODB | Substantially Equivalent | |
| K943816 | TROCARS,CANNULAE, SHEATHS | EOB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNYAccessories, Catheter, G-U
- FASElectrode, Electrosurgical, Active, Urological
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- ODBEndoscopic Contamination Prevention Sheath
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- EOBNasopharyngoscope (Flexible Or Rigid)
- ENZTelescope, Laryngeal-Bronchial
- BTRTube, Tracheal (W/Wo Connector)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain