The following data is part of a premarket notification filed by Mcginley Innovations with the FDA for Intellisense Drill.
| Device ID | K143191 |
| 510k Number | K143191 |
| Device Name: | IntelliSense Drill |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | McGinley Innovations 2435 King Blvd, Suite 230 Casper, WY 82604 |
| Contact | Joseph Mcginley |
| Correspondent | Justin Eggleton MCRA, LLC 1331 H Street NW, 12th Floor Washington, DC 20005 |
| Product Code | HWE |
| Subsequent Product Code | GEY |
| Subsequent Product Code | GFG |
| Subsequent Product Code | HTW |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-06 |
| Decision Date | 2015-02-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B666MCG100131 | K143191 | 000 |
| B666MCG130321 | K143191 | 000 |
| B666MCG130351 | K143191 | 000 |
| B666MCG130401 | K143191 | 000 |
| B666MCG130421 | K143191 | 000 |
| B666MCG130481 | K143191 | 000 |
| B666MCG160181 | K143191 | 000 |
| B666MCG160201 | K143191 | 000 |
| B666MCG160251 | K143191 | 000 |
| B666MCG160281 | K143191 | 000 |
| B666MCG160301 | K143191 | 000 |
| B666MCG160321 | K143191 | 000 |
| B666MCG160351 | K143191 | 000 |
| B666MCG160381 | K143191 | 000 |
| B666MCG130301 | K143191 | 000 |
| B666MCG130281 | K143191 | 000 |
| B666MCG100151 | K143191 | 000 |
| B666MCG100221 | K143191 | 000 |
| B666MCG100231 | K143191 | 000 |
| B666MCG100321 | K143191 | 000 |
| B666MCG130221 | K143191 | 000 |
| B666MCG100101 | K143191 | 000 |
| B666MCG100111 | K143191 | 000 |
| B666MCG100251 | K143191 | 000 |
| B666MCG130150 | K143191 | 000 |
| B666MCG130180 | K143191 | 000 |
| B666MCG130200 | K143191 | 000 |
| B666MCG130251 | K143191 | 000 |
| B666MCG130271 | K143191 | 000 |
| B666MCG160401 | K143191 | 000 |
| B666MCG160431 | K143191 | 000 |
| B666MCG160451 | K143191 | 000 |
| B666MCG3006230 | K143191 | 000 |
| B666MCG3006240 | K143191 | 000 |
| B666MCG3006251 | K143191 | 000 |
| B666MCG3006270 | K143191 | 000 |
| B666MCG3006280 | K143191 | 000 |
| B666MCG3006300 | K143191 | 000 |
| B666MCG3006320 | K143191 | 000 |
| B666MCG3006350 | K143191 | 000 |
| B666MCG3006400 | K143191 | 000 |
| B666MCG3006430 | K143191 | 000 |
| B666MCG3006450 | K143191 | 000 |
| B666MCG3006480 | K143191 | 000 |
| B666MOI30700020 | K143191 | 000 |
| B666MCG3006200 | K143191 | 000 |
| B666MCG3006190 | K143191 | 000 |
| B666MCG160481 | K143191 | 000 |
| B666MCG190201 | K143191 | 000 |
| B666MCG190321 | K143191 | 000 |
| B666MCG190381 | K143191 | 000 |
| B666MCG190421 | K143191 | 000 |
| B666MCG190481 | K143191 | 000 |
| B666MCG280481 | K143191 | 000 |
| B666MCG3006101 | K143191 | 000 |
| B666MCG3006111 | K143191 | 000 |
| B666MCG3006130 | K143191 | 000 |
| B666MCG3006150 | K143191 | 000 |
| B666MCG3006160 | K143191 | 000 |
| B666MCG3006180 | K143191 | 000 |
| B666MOI30700050 | K143191 | 000 |