SH-1 Surgical Holder for Telescope
FDA 510(k) K960068 · Olympus America, Inc.
510(k) numberK960068
Submission
- Device name
- SH-1 Surgical Holder for Telescope
- Applicant
- Olympus America, Inc.
Melville, NY, US - Received
- January 5, 1996
- Decision date
- May 5, 1997
- 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.
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| K232405 | Endofix ExoOCV · Traditional | Aktormed GmbH | 04/25/2024SE |
| K190576 | WalterLorenz Surgical Assist Arm Scope HolderOCV · Traditional | Biomet Microfixation | 06/05/2019SE |
| K102179 | Enview (TM)OCV · Traditional | Carefusion 2200 | 12/02/2010SE |
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| 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 |
| K810787 | Urologic Tube HolderOCV · Traditional | The Urology Group | 03/31/1981SE |
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Questions and answers
When was SH-1 Surgical Holder for Telescope cleared by the FDA?
SH-1 Surgical Holder for Telescope (K960068) received a 510(k) decision of Substantially Equivalent on May 5, 1997, 486 days after the submission was received.
What is the product code of K960068?
The FDA product code is OCV – Endoscope Holder, a Class II (moderate risk) device regulated under 21 CFR 876.1500.