WalterLorenz Surgical Assist Arm Scope Holder
FDA 510(k) K190576 · Biomet Microfixation
510(k) numberK190576
Submission
- Device name
- WalterLorenz Surgical Assist Arm Scope Holder
- Applicant
- Biomet Microfixation
Jacksonville, FL, US - Received
- March 6, 2019
- Decision date
- June 5, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCV – Endoscope Holder
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To hold endoscope in a desired position during procedures.
Other 510(k)s with product code OCV
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|---|---|---|---|
| K240506 | KARL STORZ HoldersOCV · Traditional | Karl Storz Endoscopy America, Inc. | 10/22/2024SE |
| K232405 | Endofix ExoOCV · Traditional | Aktormed GmbH | 04/25/2024SE |
| K102179 | Enview (TM)OCV · Traditional | Carefusion 2200 | 12/02/2010SE |
| K093616 | V. Mueller Camera Controller with Storage CartOCV · Special | Carefusion 2200 | 12/23/2009SE |
| K992006 | Neuroview Instrument Holder, Model 300-33OCV · Traditional | Integra Neurocare, LLC | 08/17/1999SE |
| K990334 | Ksea Endoscope HolderOCV · Traditional | KARL STORZ Endoscopy-America, Inc. | 03/22/1999SE |
| K971584 | Clarus Model 2127-900 Series Endoscope Adater (2127-900 Series)OCV · Traditional | Clarus Medical Systems, Inc. | 05/23/1997SE |
| K960068 | SH-1 Surgical Holder for TelescopeOCV · Traditional | Olympus America, Inc. | 05/05/1997SE |
| K810787 | Urologic Tube HolderOCV · Traditional | The Urology Group | 03/31/1981SE |
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Questions and answers
When was WalterLorenz Surgical Assist Arm Scope Holder cleared by the FDA?
WalterLorenz Surgical Assist Arm Scope Holder (K190576) received a 510(k) decision of Substantially Equivalent on June 5, 2019, 91 days after the submission was received.
What is the product code of K190576?
The FDA product code is OCV – Endoscope Holder, a Class II (moderate risk) device regulated under 21 CFR 876.1500.