The following data is part of a premarket notification filed by Insurgical Llc with the FDA for Insurgical Single Use Power Equipment.
| Device ID | K112599 |
| 510k Number | K112599 |
| Device Name: | INSURGICAL SINGLE USE POWER EQUIPMENT |
| Classification | Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment |
| Applicant | INSURGICAL LLC 8708 CAPEHART COVE Austin, TX 78733 |
| Contact | David C Furr |
| Correspondent | David C Furr INSURGICAL LLC 8708 CAPEHART COVE Austin, TX 78733 |
| Product Code | KIJ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-07 |
| Decision Date | 2012-11-06 |
| Summary: | summary |