The following data is part of a premarket notification filed by Micro- Tech (nanjing) Co., Ltd. with the FDA for Polypectomy Snare.
| Device ID | K150316 |
| 510k Number | K150316 |
| Device Name: | Polypectomy Snare |
| Classification | Snare, Flexible |
| Applicant | MICRO- TECH (NANJING) CO., LTD. NO. 10 GAOKE THIRD ROAD Nanjing, CN 210032 |
| Contact | Becky Li |
| Correspondent | Becky Li MICRO- TECH (NANJING) CO., LTD. NO. 10 GAOKE THIRD ROAD Nanjing, CN 210032 |
| Product Code | FDI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-09 |
| Decision Date | 2015-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16932503552063 | K150316 | 000 |
| 16932503551189 | K150316 | 000 |
| 16932503551172 | K150316 | 000 |
| 16932503551165 | K150316 | 000 |
| 16932503551158 | K150316 | 000 |
| 16932503551141 | K150316 | 000 |
| 16932503551134 | K150316 | 000 |
| 26932503551124 | K150316 | 000 |
| 26932503551117 | K150316 | 000 |
| 26932503551100 | K150316 | 000 |
| 26932503551094 | K150316 | 000 |
| 26932503551087 | K150316 | 000 |
| 26932503551070 | K150316 | 000 |
| 26932503551063 | K150316 | 000 |
| 26932503551056 | K150316 | 000 |
| 26932503551049 | K150316 | 000 |
| 26932503551032 | K150316 | 000 |
| 26932503551025 | K150316 | 000 |
| 16932503551196 | K150316 | 000 |
| 16932503551202 | K150316 | 000 |
| 16932503552056 | K150316 | 000 |
| 26932503552046 | K150316 | 000 |
| 26932503552039 | K150316 | 000 |
| 26932503552022 | K150316 | 000 |
| 26932503552015 | K150316 | 000 |
| 16932503551325 | K150316 | 000 |
| 16932503551318 | K150316 | 000 |
| 16932503551301 | K150316 | 000 |
| 16932503551295 | K150316 | 000 |
| 16932503551288 | K150316 | 000 |
| 16932503551271 | K150316 | 000 |
| 16932503551264 | K150316 | 000 |
| 16932503551257 | K150316 | 000 |
| 16932503551240 | K150316 | 000 |
| 16932503551233 | K150316 | 000 |
| 16932503551226 | K150316 | 000 |
| 16932503551219 | K150316 | 000 |
| 26932503551018 | K150316 | 000 |