The following data is part of a premarket notification filed by Lumenis Ltd. with the FDA for Versacut + Tissue Morcellator.
| Device ID | K133272 |
| 510k Number | K133272 |
| Device Name: | VERSACUT + TISSUE MORCELLATOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | LUMENIS LTD. 31 HAAVODA ST. Binyamina, IL 30500 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy LUMENIS LTD. 31 HAAVODA ST. Binyamina, IL 30500 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-24 |
| Decision Date | 2014-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109143156 | K133272 | 000 |
| 07290109142494 | K133272 | 000 |
| 07290109141992 | K133272 | 000 |
| 07290109141961 | K133272 | 000 |
| 07290109140650 | K133272 | 000 |
| 07290109140643 | K133272 | 000 |
| 07290109140636 | K133272 | 000 |