The following data is part of a premarket notification filed by Karl Storz Endoscopy America, Inc. with the FDA for Unidrive S Iii Ent 40701601-1 With Karl Storz-scb, Drillcut-x Ii Shaver Handpiece, High Speed Ec Micromotor Ii For Use With Intra Drill Handpieces.
| Device ID | K150969 |
| 510k Number | K150969 |
| Device Name: | Unidrive S III ENT 40701601-1 With KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II For Use With INTRA Drill Handpieces |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | KARL STORZ ENDOSCOPY AMERICA, INC. 2151 E. GRAND AVE El Segundo, CA 90245 |
| Contact | Jennifer Michelle Chambers |
| Correspondent | Jennifer Michelle Chambers KARL STORZ ENDOSCOPY AMERICA, INC. 2151 E. GRAND AVE El Segundo, CA 90245 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-13 |
| Decision Date | 2016-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551313848 | K150969 | 000 |
| 04048551313824 | K150969 | 000 |
| 04048551313695 | K150969 | 000 |
| 04048551313640 | K150969 | 000 |
| 04048551317266 | K150969 | 000 |
| 04048551313831 | K150969 | 000 |
| 04048551313800 | K150969 | 000 |