The following data is part of a premarket notification filed by Covidien with the FDA for Gia Auto Suture Stapler With Dst Series Technology.
Device ID | K221013 |
510k Number | K221013 |
Device Name: | GIA Auto Suture Stapler With DST Series Technology |
Classification | Staple, Implantable |
Applicant | Covidien 60 Middletown Avenue North Haven, CT 06473 |
Contact | Robert Zott |
Correspondent | Angela Van Arsdale Covidien 60 Middletown Avenue North Haven, CT 06473 |
Product Code | GDW |
CFR Regulation Number | 878.4750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-04-05 |
Decision Date | 2022-05-05 |