Fiberoptic Wire Pick Lightpipe
FDA 510(k) K883857 · Advanced Surgical Products, Inc.
510(k) numberK883857
Submission
- Device name
- Fiberoptic Wire Pick Lightpipe
- Applicant
- Advanced Surgical Products, Inc.
Chesterfield, MO, US - Received
- September 13, 1988
- Decision date
- September 29, 1988
- 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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| K884557 | Advanced Surgical Products Scissors HandpieceHQE · Traditional | 05/12/1989SE |
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| K890398 | Ryan-Style Directed Infusion ManipulatorHBI · Traditional | 02/17/1989SE |
| K884347 | Modified Disposable Coaxial Bipolar PenGXI · Traditional | 12/27/1988SE |
| K883858 | Fiberoptic Sharp Integral Pick LightpipeHBI · Traditional | 09/29/1988SE |
| K883856 | Fiberoptic Blunt Integral Pick LightpipeHBI · Traditional | 09/29/1988SE |
Questions and answers
When was Fiberoptic Wire Pick Lightpipe cleared by the FDA?
Fiberoptic Wire Pick Lightpipe (K883857) received a 510(k) decision of Substantially Equivalent on September 29, 1988, 16 days after the submission was received.
What is the product code of K883857?
The FDA product code is HBI – Illuminator, Fiberoptic, Surgical Field, a Class II (moderate risk) device regulated under 21 CFR 878.4580.