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 |