GEJ · Class I · 21 CFR 878.4800

FDA Product Code GEJ: Carrier, Ligature

Leading manufacturers include Solos Endoscopy, Inc., Cypris Medical and Cook Ob/Gyn.

5
Total
5
Cleared
48d
Avg days
1987
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Carrier, Ligature Devices (Product Code GEJ)

5 devices
1–5 of 5
Cleared May 03, 2024
Cypris eXact Suture Placement Device
K240185
Cypris Medical
General & Plastic Surgery · 101d
Cleared Apr 18, 1990
GS-1300 ATRAUMATIC GRASPING FORCEP, CURVED, 10MM
K900958
Solos Endoscopy, Inc.
General & Plastic Surgery · 50d
Cleared Apr 18, 1990
GS-1400 TOOTHED DISSECTING FORCEP, 5MM, INSULATED
K900959
Solos Endoscopy, Inc.
General & Plastic Surgery · 50d
Cleared Nov 14, 1988
STAMEY NEEDLE
K884553
Cook Ob/Gyn
General & Plastic Surgery · 14d

About Product Code GEJ - Regulatory Context

510(k) Submission Activity

5 total 510(k) submissions under product code GEJ since 1987, with 5 receiving FDA clearance (average review time: 48 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.