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 |