The following data is part of a premarket notification filed by Invuity, Inc. with the FDA for Invuity Britefield Mcculloch Retractor System.
| Device ID | K090070 |
| 510k Number | K090070 |
| Device Name: | INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | INVUITY, INC. 155-A MOFFETT PARK DRIVE SUITE 210 Sunnyvale, CA 94089 |
| Contact | Kit Cariquitan |
| Correspondent | Kit Cariquitan INVUITY, INC. 155-A MOFFETT PARK DRIVE SUITE 210 Sunnyvale, CA 94089 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-12 |
| Decision Date | 2009-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816728020318 | K090070 | 000 |
| 00816728020165 | K090070 | 000 |
| 00816728020172 | K090070 | 000 |
| 00816728020189 | K090070 | 000 |
| 00816728020196 | K090070 | 000 |
| 00816728020202 | K090070 | 000 |
| 00816728020219 | K090070 | 000 |
| 00816728020226 | K090070 | 000 |
| 00816728020233 | K090070 | 000 |
| 00816728020240 | K090070 | 000 |
| 00816728020257 | K090070 | 000 |
| 00816728020264 | K090070 | 000 |
| 00816728020271 | K090070 | 000 |
| 00816728020288 | K090070 | 000 |
| 00816728020295 | K090070 | 000 |
| 00816728020301 | K090070 | 000 |
| 00816728020059 | K090070 | 000 |