The following data is part of a premarket notification filed by Prosurg, Inc with the FDA for Neo - Arthroscope (rigid) 2.0mm/3.5mm, Outer Sheath/ Cannula, Outer Sheath/ Cannula W/ Handle, Trocar For Outersheath/ Cannula.
| Device ID | K152511 |
| 510k Number | K152511 |
| Device Name: | Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer Sheath/ Cannula, Outer Sheath/ Cannula W/ Handle, Trocar For Outersheath/ Cannula |
| Classification | Arthroscope |
| Applicant | PROSURG, INC 2193 TRADE ZONE BLVD San Jose, CA 95131 |
| Contact | Ashvin Desai |
| Correspondent | Ashvin Desai PROSURG, INC 2193 TRADE ZONE BLVD San Jose, CA 95131 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-02 |
| Decision Date | 2016-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10851545007811 | K152511 | 000 |
| 10851545007729 | K152511 | 000 |
| 10851545007712 | K152511 | 000 |