Olympus PF-18 & PF-25 Ultrathin Angioscope
FDA 510(k) K860858 · Olympus Corp.
510(k) numberK860858
Submission
- Device name
- Olympus PF-18 & PF-25 Ultrathin Angioscope
- Applicant
- Olympus Corp.
Lake Success, NY, US - Received
- March 7, 1986
- Decision date
- November 20, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LYK – Angioscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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| K251767 | Vena MicroAngioscope SystemLYK · Traditional | Vena Medical Holdings Corp | 10/01/2025SE |
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| K012724 | Smith & Nephew Vascular Videoendoscope System, Model 7209273LYK · Traditional | Smith & Nephew, Inc. | 11/08/2001SE |
| K001408 | Ksea Vascular FiberscopesLYK · Traditional | KARL STORZ Endoscopy-America, Inc. | 10/30/2000SE |
| K964061 | Gore Angioscopic Valvvlotome Kit (TBD)LYK · Traditional | W. L. Gore & Associates, Inc. | 02/20/1997SE |
| K952638 | 4.5F Imagecath Coronary Angioscope, Model COV45 [Subsequently Referred to AS the…LYK · Traditional | Baxter Edwards | 07/28/1995SE |
| K951721 | Applied Medical 1.5MM Reusable AngioscopeLYK · Traditional | Applied Medical Resources | 07/11/1995SE |
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Questions and answers
When was Olympus PF-18 & PF-25 Ultrathin Angioscope cleared by the FDA?
Olympus PF-18 & PF-25 Ultrathin Angioscope (K860858) received a 510(k) decision of Substantially Equivalent on November 20, 1986, 258 days after the submission was received.
What is the product code of K860858?
The FDA product code is LYK – Angioscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.