The following data is part of a premarket notification filed by Liger Medical, Llc with the FDA for Liger Medical Htu-110.
| Device ID | K152843 |
| 510k Number | K152843 |
| Device Name: | Liger Medical HTU-110 |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | LIGER MEDICAL, LLC 14062 S RUNNING CREEK WAY Draper, UT 84020 |
| Contact | Steve Smith |
| Correspondent | Steve Smith LIGER MEDICAL, LLC 14062 S RUNNING CREEK WAY Draper, UT 84020 |
| Product Code | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-29 |
| Decision Date | 2016-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861592000355 | K152843 | 000 |
| 00861592000348 | K152843 | 000 |
| 00861592000331 | K152843 | 000 |
| 00861592000324 | K152843 | 000 |