The following data is part of a premarket notification filed by Karl Storz Endoskop Gmbh with the FDA for Trocars,cannulae,sheaths,obturators.
| Device ID | K943697 |
| 510k Number | K943697 |
| Device Name: | TROCARS,CANNULAE,SHEATHS,OBTURATORS |
| Classification | Endoscopic Contamination Prevention Sheath |
| Applicant | KARL STORZ ENDOSKOP GMBH 600 CORPORATE POINTE Culver City, CA 90230 |
| Contact | Marika Anderson |
| Correspondent | Marika Anderson KARL STORZ ENDOSKOP GMBH 600 CORPORATE POINTE Culver City, CA 90230 |
| Product Code | ODB |
| Subsequent Product Code | FBQ |
| Subsequent Product Code | FEC |
| Subsequent Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-29 |
| Decision Date | 1994-09-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551323199 | K943697 | 000 |
| 04048551080542 | K943697 | 000 |
| 04048551080504 | K943697 | 000 |
| 04048551080481 | K943697 | 000 |
| 04048551232194 | K943697 | 000 |