The following data is part of a premarket notification filed by Covidien with the FDA for Auto Suture Locking Trocar.
Device ID | K152565 |
510k Number | K152565 |
Device Name: | Auto Suture Locking Trocar |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | COVIDIEN 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
Contact | Michael Koczocik |
Correspondent | Michael Koczocik COVIDIEN 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-09-09 |
Decision Date | 2015-10-09 |
Summary: | summary |