The following data is part of a premarket notification filed by Micromedics, Inc. with the FDA for 360 Gas Assisted Endoscopic Applicator.
| Device ID | K122526 |
| 510k Number | K122526 |
| Device Name: | 360 GAS ASSISTED ENDOSCOPIC APPLICATOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MICROMEDICS, INC. 1270 Eagan Industrial Rd Ste 120 Saint Paul, MN 55121 |
| Contact | Jodi L Raus |
| Correspondent | Jodi L Raus MICROMEDICS, INC. 1270 Eagan Industrial Rd Ste 120 Saint Paul, MN 55121 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-20 |
| Decision Date | 2012-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815634020672 | K122526 | 000 |
| 20815634020508 | K122526 | 000 |
| 00815634020368 | K122526 | 000 |
| 00815634020238 | K122526 | 000 |
| 10815634020600 | K122526 | 000 |