ISurg
Electrosurgical, Cutting & Coagulation & Accessories
JACO, LLC Dba Macan Manufacturing And BNA Burz North America
The following data is part of a premarket notification filed by Jaco, Llc Dba Macan Manufacturing And Bna Burz North America with the FDA for Isurg.
Pre-market Notification Details
| Device ID | K170054 |
| 510k Number | K170054 |
| Device Name: | ISurg |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | JACO, LLC Dba Macan Manufacturing And BNA Burz North America 21 Shay Lane Milton, DE 19968 |
| Contact | John Marsillo |
| Correspondent | Bill Mclain Keystone Regulatory Services, LLC 342 East Main Street, Suite 207 Leola, PA 17540 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-06 |
| Decision Date | 2017-10-02 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853404007539 | K170054 | 000 |
| 00853404007522 | K170054 | 000 |
| 00851683006137 | K170054 | 000 |
Trademark Results [ISurg]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ISURG 86639789 4880597 Live/Registered |
GARITO, JON, DR. 2015-05-22 |
 ISURG 77669917 not registered Dead/Abandoned |
TYCO HEALTHCARE GROUP LP 2009-02-13 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.