The following data is part of a premarket notification filed by Guilin Woodpecker Medical Instrument Co., Ltd. with the FDA for Apex Locator, Dpex Iii.
| Device ID | K181087 |
| 510k Number | K181087 |
| Device Name: | Apex Locator, DPEX III |
| Classification | Locator, Root Apex |
| Applicant | Guilin Woodpecker Medical Instrument Co., Ltd. Information Industrial Park, Guilin National High-Tech Zone Guilin City, CN 541004 |
| Contact | Xunxian Wu |
| Correspondent | Charlie Mack IRC 2950 E Lindrick Drive Chandler, AZ 85249 |
| Product Code | LQY |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-25 |
| Decision Date | 2018-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10304040110604 | K181087 | 000 |
| 00837699000161 | K181087 | 000 |
| 00837699000031 | K181087 | 000 |
| 00837699000130 | K181087 | 000 |
| 00810988031299 | K181087 | 000 |
| 00810988031329 | K181087 | 000 |
| 00810988031305 | K181087 | 000 |
| 00810988031350 | K181087 | 000 |
| 00810988031336 | K181087 | 000 |
| 00810988031312 | K181087 | 000 |
| 00990010301221 | K181087 | 000 |
| 00990010301351 | K181087 | 000 |
| 00990010301320 | K181087 | 000 |
| 00818365028962 | K181087 | 000 |
| 00818365028955 | K181087 | 000 |
| 00818365028948 | K181087 | 000 |
| 00818365028931 | K181087 | 000 |
| 10818365028921 | K181087 | 000 |
| 06944843603001 | K181087 | 000 |
| 06944843603018 | K181087 | 000 |
| 10304040110598 | K181087 | 000 |
| 00304040110614 | K181087 | 000 |
| 00304040110584 | K181087 | 000 |
| 00304040110577 | K181087 | 000 |
| 00304040108932 | K181087 | 000 |
| 06944843605821 | K181087 | 000 |
| 06944843605579 | K181087 | 000 |
| 06944843605401 | K181087 | 000 |
| 06944843604497 | K181087 | 000 |
| 06944843604282 | K181087 | 000 |
| 06944843611075 | K181087 | 000 |
| 06944843603070 | K181087 | 000 |
| 06944843603063 | K181087 | 000 |
| 06944843603056 | K181087 | 000 |
| 06944843603049 | K181087 | 000 |
| 06944843603032 | K181087 | 000 |
| 06944843603025 | K181087 | 000 |
| 00818365028900 | K181087 | 000 |