Prisma Dispos. Brite Lite Fiberoptic Endoillumina.
FDA 510(k) K875007 · Advanced Surgical Products, Inc.
510(k) numberK875007
Submission
- Device name
- Prisma Dispos. Brite Lite Fiberoptic Endoillumina.
- Applicant
- Advanced Surgical Products, Inc.
Chesterfield, MO, US - Received
- December 4, 1987
- Decision date
- March 14, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FST – Light, Surgical, Fiberoptic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
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| K030926 | Fast Throw Stainless Steel Surgical SutureFZP · Traditional | 07/21/2003SE |
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| K896754 | I/A HandpieceHQE · Traditional | 01/11/1990SE |
| K896305 | Multi-Use I/A HandpieceHQE · Traditional | 12/18/1989SE |
| K884557 | Advanced Surgical Products Scissors HandpieceHQE · Traditional | 05/12/1989SE |
| K884556 | Dreyer Curved EndoilluminatorHQE · Traditional | 02/28/1989SE |
| 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 |
| K883857 | Fiberoptic Wire Pick LightpipeHBI · Traditional | 09/29/1988SE |
Questions and answers
When was Prisma Dispos. Brite Lite Fiberoptic Endoillumina. cleared by the FDA?
Prisma Dispos. Brite Lite Fiberoptic Endoillumina. (K875007) received a 510(k) decision of Substantially Equivalent on March 14, 1988, 101 days after the submission was received.
What is the product code of K875007?
The FDA product code is FST – Light, Surgical, Fiberoptic, a Class II (moderate risk) device regulated under 21 CFR 878.4580.