Endoscope Holder
The Endoscope Holder (product code OCV) is a gastroenterology and urology accessory used to hold an endoscope in a desired position during diagnostic or therapeutic procedures, freeing the clinician's hands and stabilizing the instrument. Stable endoscope positioning is important for precision during complex endoscopic interventions. This device is FDA Class 2 under regulation 876.1500 in the Gastroenterology, Urology specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.
Basic Information
- Product Code
- OCV
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
To hold endoscope in a desired position during procedures.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K240506 | KARL STORZ Holders | Oct 22, 2024 | Substantially Equivalent | KARL STORZ Endoscopy America, Inc |
| K232405 | ENDOFIX EXO | Apr 25, 2024 | Substantially Equivalent | AKTORmed GmbH |
| K190576 | WalterLorenz Surgical Assist Arm Scope Holder | Jun 05, 2019 | Substantially Equivalent | Biomet Microfixation |
| K102179 | ENVIEW (TM) | Dec 02, 2010 | Substantially Equivalent | CAREFUSION 2200 |
| K093616 | V. MUELLER CAMERA CONTROLLER WITH STORAGE CART | Dec 23, 2009 | Substantially Equivalent | CAREFUSION 2200 |
| K992006 | NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33 | Aug 17, 1999 | Substantially Equivalent | INTEGRA NEUROCARE LLC. |
| K990334 | KSEA ENDOSCOPE HOLDER | Mar 22, 1999 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K971584 | CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES) | May 23, 1997 | Substantially Equivalent | CLARUS MEDICAL SYSTEMS, INC. |
| K960068 | SH-1 SURGICAL HOLDER FOR TELESCOPE | May 05, 1997 | Substantially Equivalent | OLYMPUS AMERICA, INC. |
| K810787 | UROLOGIC TUBE HOLDER | Mar 31, 1981 | Substantially Equivalent | THE UROLOGY GROUP |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.