The following data is part of a premarket notification filed by Trokamed Gmbh with the FDA for Trokamed Morcellator.
| Device ID | K091010 |
| 510k Number | K091010 |
| Device Name: | TROKAMED MORCELLATOR |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | TROKAMED GMBH AMSTEL 320-I Amsterdam, NL 1017ap |
| Contact | Angelika Scherp |
| Correspondent | Angelika Scherp TROKAMED GMBH AMSTEL 320-I Amsterdam, NL 1017ap |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-09 |
| Decision Date | 2011-03-01 |
| Summary: | summary |