The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Ltd. with the FDA for Sphincterotome / Short-wire Compatible, Sterile Sphincterotome.
| Device ID | K210934 |
| 510k Number | K210934 |
| Device Name: | Sphincterotome / Short-wire Compatible, Sterile Sphincterotome |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | Micro-Tech (Nanjing) Co., Ltd. No. 10 Gaoke Third Road, Nanjing National Hi-tech Industrial Development Zone Nanjing, CN 210032 |
| Contact | Sally He |
| Correspondent | Sally He Micro-Tech (Nanjing) Co., Ltd. No. 10 Gaoke Third Road, Nanjing National Hi-tech Industrial Development Zone Nanjing, CN 210032 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-29 |
| Decision Date | 2021-12-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16932503575369 | K210934 | 000 |
| 16932503575178 | K210934 | 000 |
| 16932503575161 | K210934 | 000 |
| 16932503575154 | K210934 | 000 |
| 16932503575147 | K210934 | 000 |
| 16932503575130 | K210934 | 000 |
| 16932503575123 | K210934 | 000 |
| 16932503575116 | K210934 | 000 |
| 16932503575109 | K210934 | 000 |
| 16932503575093 | K210934 | 000 |
| 16932503575086 | K210934 | 000 |
| 16932503575079 | K210934 | 000 |
| 16932503575062 | K210934 | 000 |
| 16932503575055 | K210934 | 000 |
| 16932503575048 | K210934 | 000 |
| 16932503575031 | K210934 | 000 |
| 16932503575024 | K210934 | 000 |
| 16932503575185 | K210934 | 000 |
| 16932503575192 | K210934 | 000 |
| 16932503575352 | K210934 | 000 |
| 16932503575345 | K210934 | 000 |
| 16932503575338 | K210934 | 000 |
| 16932503575321 | K210934 | 000 |
| 16932503575314 | K210934 | 000 |
| 16932503575307 | K210934 | 000 |
| 16932503575291 | K210934 | 000 |
| 16932503575284 | K210934 | 000 |
| 16932503575277 | K210934 | 000 |
| 16932503575260 | K210934 | 000 |
| 16932503575253 | K210934 | 000 |
| 16932503575246 | K210934 | 000 |
| 16932503575239 | K210934 | 000 |
| 16932503575222 | K210934 | 000 |
| 16932503575215 | K210934 | 000 |
| 16932503575208 | K210934 | 000 |
| 16932503575017 | K210934 | 000 |