FEO · Class II · 21 CFR 876.4480

FDA Product Code FEO: Lithotriptor, Ultrasonic

Leading manufacturers include E.M.S Electro Medical Systems S.A and KARL STORZ Endoscopy-America, Inc..

14
Total
14
Cleared
127d
Avg days
1984
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Lithotriptor, Ultrasonic Devices (Product Code FEO)

14 devices
1–14 of 14
Cleared Oct 23, 2023
Swiss LthoClast Trilogy
K230893
E.M.S Electro Medical Systems S.A
Gastroenterology & Urology · 206d
Cleared Oct 09, 2018
Swiss LithoClast Trilogy
K182490
E.M.S Electro Medical Systems S.A
Gastroenterology & Urology · 28d
Cleared Aug 30, 2018
Swiss LithoClast Trilogy
K181997
E.M.S Electro Medical Systems S.A
Gastroenterology & Urology · 35d
Cleared Jun 20, 2018
Swiss LithoClast Trilogy
K181364
E.M.S Electro Medical Systems S.A
Gastroenterology & Urology · 28d
Cleared Jan 10, 2018
Swiss LithoClast Trilogy
K173234
E.M.S Electro Medical Systems S.A
Gastroenterology & Urology · 97d
Cleared Jun 22, 1998
KSEA CALCUSON
K973251
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 297d
Cleared Dec 11, 1984
KARL STORZ 27086KC ULTRASONIC LITHOTRI
K843101
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 126d

About Product Code FEO - Regulatory Context

510(k) Submission Activity

14 total 510(k) submissions under product code FEO since 1984, with 14 receiving FDA clearance (average review time: 127 days).

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