Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K241333
Geniant Cranial (Navigated Neurosurgical Positioning Robot) · Koh Young Technology, Inc. · decided 2025-01-17 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Geniant Cranial | KY-CON-0030-A | KOH YOUNG TECHNOLOGY INC. | HAW | 08800050902642 |
| Geniant Cranial | M_MN30-KHC0000 | KOH YOUNG TECHNOLOGY INC. | HAW | 08800050902574 |
| Geniant Cranial | MN30-CRAB180 | KOH YOUNG TECHNOLOGY INC. | HAW | 08800050902338 |
| Geniant Cranial | MN30-CRAB025 | KOH YOUNG TECHNOLOGY INC. | HAW | 08800050902307 |
| Geniant Cranial | MN30-KF00080 | KOH YOUNG TECHNOLOGY INC. | HAW | 08800050902062 |
| Geniant Cranial | MN30-CRGB001 | KOH YOUNG TECHNOLOGY INC. | HAW | 08800050902239 |
| Geniant Cranial | MN30-CNGK002 | KOH YOUNG TECHNOLOGY INC. | HAW | 08800050901737 |
| Geniant Cranial | MN30-CRS0001 | KOH YOUNG TECHNOLOGY INC. | HAW | 08800050901591 |
| Geniant Cranial | MN30-KH00009 | KOH YOUNG TECHNOLOGY INC. | HAW | 08800050901867 |
| Geniant Cranial | M_MN30-CNAB000 | KOH YOUNG TECHNOLOGY INC. | HAW | 08800050901492 |
| Geniant Cranial | KY-SMS-0030-B | KOH YOUNG TECHNOLOGY INC. | HAW | 08800050902659 |
| Geniant Cranial | MN30-KF00035 | KOH YOUNG TECHNOLOGY INC. | HAW | 08800050901973 |
| Geniant Cranial | MN30-KH00014 | KOH YOUNG TECHNOLOGY INC. | HAW | 08800050901911 |
| Geniant Cranial | MN30-CRGB210 | KOH YOUNG TECHNOLOGY INC. | HAW | 08800050901560 |
| Geniant Cranial | M_MN30-CSDB000 | KOH YOUNG TECHNOLOGY INC. | HAW | 08800050902505 |
| Geniant Cranial | M_MN30-CNAM000 | KOH YOUNG TECHNOLOGY INC. | HAW | 08800050901485 |
| Geniant Cranial | MN30-CRSC004 | KOH YOUNG TECHNOLOGY INC. | HAW | 08800050901645 |
| Geniant Cranial | M_MN30-KFT0000 | KOH YOUNG TECHNOLOGY INC. | HAW | 08800050902109 |
| Geniant Cranial | MN30-CRAB250 | KOH YOUNG TECHNOLOGY INC. | HAW | 08800050902291 |
| Geniant Cranial | MN30-CRGB180 | KOH YOUNG TECHNOLOGY INC. | HAW | 08800050901553 |
| Geniant Cranial | MN30-CRGB320 | KOH YOUNG TECHNOLOGY INC. | HAW | 08800050901546 |
| Geniant Cranial | M_MN30-K000000 | KOH YOUNG TECHNOLOGY INC. | HAW | 08800050902468 |
| Geniant Cranial | MN30-CRGB250 | KOH YOUNG TECHNOLOGY INC. | HAW | 08800050901584 |
| Geniant Cranial | MN30-CRS0002 | KOH YOUNG TECHNOLOGY INC. | HAW | 08800050901607 |
| Geniant Cranial | M_MN30-CMH0000 | KOH YOUNG TECHNOLOGY INC. | HAW | 08800050901386 |