Ryan-Style Directed Infusion Manipulator
FDA 510(k) K890398 · Advanced Surgical Products, Inc.
510(k) numberK890398
Submission
- Device name
- Ryan-Style Directed Infusion Manipulator
- Applicant
- Advanced Surgical Products, Inc.
Chesterfield, MO, US - Received
- January 24, 1989
- Decision date
- February 17, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HBI – Illuminator, Fiberoptic, Surgical Field
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
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| K052979 | 1125 XSB Xenon Fiber-Optic Light SourceHBI · Traditional | Isolux, LLC | 10/31/2005SE |
| K021931 | Endoscopic Fiberoptic CableHBI · Traditional | Gulf Medical Fiberoptics | 09/06/2002SE |
| K991208 | Endoscopic Fiberoptic CableHBI · Traditional | Isolux America | 06/23/1999SE |
| K983277 | Lightsource or Illuminator Model I-100HBI · Traditional | Cuda Products Co. | 12/16/1998SE |
| K933593 | Luminous 150 Fiberoptic IlluminatorHBI · Traditional | Progressive Dynamics, Inc. | 10/28/1993SE |
| K922837 | S1500 Xenon Light SourceHBI · Traditional | Endomedix | 11/03/1992SE |
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| K883858 | Fiberoptic Sharp Integral Pick LightpipeHBI · Traditional | 09/29/1988SE |
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Questions and answers
When was Ryan-Style Directed Infusion Manipulator cleared by the FDA?
Ryan-Style Directed Infusion Manipulator (K890398) received a 510(k) decision of Substantially Equivalent on February 17, 1989, 24 days after the submission was received.
What is the product code of K890398?
The FDA product code is HBI – Illuminator, Fiberoptic, Surgical Field, a Class II (moderate risk) device regulated under 21 CFR 878.4580.