The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea Unidrive Ent/neuro/omfs System And Accessories.
| Device ID | K053262 |
| 510k Number | K053262 |
| Device Name: | KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Yvonne Fernandez |
| Correspondent | Yvonne Fernandez KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-22 |
| Decision Date | 2005-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551086940 | K053262 | 000 |
| 04048551086902 | K053262 | 000 |
| 04048551086889 | K053262 | 000 |
| 04048551358849 | K053262 | 000 |
| 04048551358740 | K053262 | 000 |
| 04048551358856 | K053262 | 000 |
| 04048551071670 | K053262 | 000 |