GYK · Class I · 21 CFR 882.4545

FDA Product Code GYK: Instrument, Shunt System Implantation

Leading manufacturers include Cordis Corp., Baxter Healthcare Corp and Cook, Inc..

13
Total
13
Cleared
58d
Avg days
1977
Since

FDA 510(k) Cleared Instrument, Shunt System Implantation Devices (Product Code GYK)

13 devices
1–13 of 13
Cleared Oct 11, 1996
REIGEL TUNNELING DEVICE
K962761
Cook, Inc.
Neurology · 87d
Cleared Aug 23, 1993
CORDIS TUNNELER
K932273
Cordis Corp.
Neurology · 102d
Cleared Oct 31, 1989
HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE
K895868
Baxter Healthcare Corp
Neurology · 27d
Cleared Aug 16, 1977
PERITONEAL INTRODUCER & SHEATH
K771529
Cordis Corp.
Neurology · 8d

About Product Code GYK - Regulatory Context