The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Retractore, Probes, Dissectors, Hooks, Uterineelevators, Uterine Cannulae.
| Device ID | K945211 |
| 510k Number | K945211 |
| Device Name: | KARL STORZ RETRACTORE, PROBES, DISSECTORS, HOOKS, UTERINEELEVATORS, UTERINE CANNULAE |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Marika Anderson |
| Correspondent | Marika Anderson KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-25 |
| Decision Date | 1995-03-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551099063 | K945211 | 000 |
| 04048551457191 | K945211 | 000 |
| 04048551457207 | K945211 | 000 |
| 04048551258095 | K945211 | 000 |
| 04048551364963 | K945211 | 000 |
| 04048551094303 | K945211 | 000 |
| 04048551095843 | K945211 | 000 |
| 04048551095867 | K945211 | 000 |
| 04048551099315 | K945211 | 000 |
| 04048551099339 | K945211 | 000 |
| 04048551099353 | K945211 | 000 |
| 04048551099476 | K945211 | 000 |
| 04048551101766 | K945211 | 000 |
| 04048551099001 | K945211 | 000 |
| 04048551099025 | K945211 | 000 |
| 04048551099049 | K945211 | 000 |
| 04048551457184 | K945211 | 000 |