OCV · Class II · 21 CFR 876.1500

FDA Product Code OCV: Endoscope Holder

To Hold Endoscope In A Desired Position During Procedures.

Leading manufacturers include Carefusion 2200, KARL STORZ Endoscopy-America, Inc. and Clarus Medical Systems, Inc..

10
Total
10
Cleared
138d
Avg days
1981
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Endoscope Holder Devices (Product Code OCV)

10 devices
1–10 of 10
Cleared Oct 22, 2024
KARL STORZ Holders
K240506
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 244d
Cleared Apr 25, 2024
ENDOFIX EXO
K232405
Aktormed GmbH
General & Plastic Surgery · 259d
Cleared Jun 05, 2019
WalterLorenz Surgical Assist Arm Scope Holder
K190576
Biomet Microfixation
General & Plastic Surgery · 91d
Cleared Dec 02, 2010
ENVIEW (TM)
K102179
Carefusion 2200
Gastroenterology & Urology · 121d
Cleared Dec 23, 2009
V. MUELLER CAMERA CONTROLLER WITH STORAGE CART
K093616
Carefusion 2200
Gastroenterology & Urology · 34d
Cleared Aug 17, 1999
NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33
K992006
Integra Neurocare, LLC
Gastroenterology & Urology · 63d
Cleared Mar 22, 1999
KSEA ENDOSCOPE HOLDER
K990334
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 47d
Cleared May 23, 1997
CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES)
K971584
Clarus Medical Systems, Inc.
Gastroenterology & Urology · 23d
Cleared May 05, 1997
SH-1 SURGICAL HOLDER FOR TELESCOPE
K960068
Olympus America, Inc.
Gastroenterology & Urology · 486d
Cleared Mar 31, 1981
UROLOGIC TUBE HOLDER
K810787
The Urology Group
Gastroenterology & Urology · 8d

About Product Code OCV - Regulatory Context

510(k) Submission Activity

10 total 510(k) submissions under product code OCV since 1981, with 10 receiving FDA clearance (average review time: 138 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.