The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea Rotocut G1 Electromechanical Morcellator.
| Device ID | K061180 |
| 510k Number | K061180 |
| Device Name: | KSEA ROTOCUT G1 ELECTROMECHANICAL MORCELLATOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | James Lee |
| Correspondent | Leigh Spotten KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-27 |
| Decision Date | 2006-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551323755 | K061180 | 000 |
| 04048551263709 | K061180 | 000 |