The following data is part of a premarket notification filed by Spr Therapeutics, Inc. with the FDA for Sprint Peripheral Nerve Stimulation System, Extensa, Sprint Peripheral Nerve Stimulation System, Endura, Sprint Clinical Programmer Kit.
| Device ID | K181422 |
| 510k Number | K181422 |
| Device Name: | SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit |
| Classification | Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief |
| Applicant | SPR Therapeutics, Inc. 22901 Millcreek Blvd, Suite 110 Cleveland, OH 44122 |
| Contact | Kathryn Stager |
| Correspondent | Kathryn Stager SPR Therapeutics, Inc. 22901 Millcreek Blvd, Suite 110 Cleveland, OH 44122 |
| Product Code | NHI |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-31 |
| Decision Date | 2018-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854001007960 | K181422 | 000 |
| 00854001007762 | K181422 | 000 |
| 00854001007755 | K181422 | 000 |
| 00854001007748 | K181422 | 000 |
| 00854001007731 | K181422 | 000 |
| 00854001007724 | K181422 | 000 |
| 00854001007717 | K181422 | 000 |
| 00854001007663 | K181422 | 000 |
| 00854001007656 | K181422 | 000 |
| 00854001007649 | K181422 | 000 |
| 00854001007632 | K181422 | 000 |
| 00854001007984 | K181422 | 000 |
| 00854001007977 | K181422 | 000 |
| 00850022775062 | K181422 | 000 |
| 00850022775055 | K181422 | 000 |
| 00850022775048 | K181422 | 000 |
| 00854001007779 | K181422 | 000 |
| 00854001007786 | K181422 | 000 |
| 00854001007953 | K181422 | 000 |
| 00854001007922 | K181422 | 000 |
| 00854001007915 | K181422 | 000 |
| 00854001007908 | K181422 | 000 |
| 00854001007892 | K181422 | 000 |
| 00854001007885 | K181422 | 000 |
| 00854001007878 | K181422 | 000 |
| 00854001007861 | K181422 | 000 |
| 00854001007854 | K181422 | 000 |
| 00854001007847 | K181422 | 000 |
| 00854001007830 | K181422 | 000 |
| 00854001007823 | K181422 | 000 |
| 00854001007816 | K181422 | 000 |
| 00854001007809 | K181422 | 000 |
| 00854001007793 | K181422 | 000 |
| 00854001007540 | K181422 | 000 |