The following data is part of a premarket notification filed by Purple Surgical International Limited with the FDA for 5mm Laparoscopic Electrode With J Hook, 5mm Laparoscopic Electrode With L Hook, 5mm Laparoscopic Electrode With Spatula, Monopolar Cable With 4mm Pin, Monopolar Cable With 8mm Pin.
| Device ID | K142868 |
| 510k Number | K142868 |
| Device Name: | 5mm Laparoscopic Electrode With J Hook, 5mm Laparoscopic Electrode With L Hook, 5mm Laparoscopic Electrode With Spatula, Monopolar Cable With 4mm Pin, Monopolar Cable With 8mm Pin |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Purple Surgical International Limited 2 Chestnut House, Farm Close, Shenley, GB Wd7 9ad |
| Contact | Jason Howes |
| Correspondent | Alan Schwartz MDI CONSULTANTS, INC 55 NORTHERN BLVD., STE 200 Great Neck, NY 11021 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-01 |
| Decision Date | 2014-11-21 |
| Summary: | summary |