Visi-Wipe
FDA 510(k) K884924 · Visitec Co.
510(k) numberK884924
Submission
- Device name
- Visi-Wipe
- Applicant
- Visitec Co.
Sarasota, FL, US - Received
- November 28, 1988
- Decision date
- January 31, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HOF – Burr, Corneal, Manual
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
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| K942234 | Visitec Precise-PointGAP · Traditional | 07/12/1994SE |
| K934269 | Fiberoptic Illuminated InstrumentsHJM · Traditional | 05/17/1994SE |
| K940210 | Visitec Eye PadEFQ · Traditional | 03/07/1994SE |
| K933872 | Visi-Spear Eye SpongeHOZ · Traditional | 12/27/1993SE |
| K923972 | Ophthalmic Fluid Distribution SetsFPK · Traditional | 11/04/1992SE |
| K922530 | Visitec Microsurgical SutureGAR · Traditional | 10/20/1992SE |
Questions and answers
When was Visi-Wipe cleared by the FDA?
Visi-Wipe (K884924) received a 510(k) decision of Substantially Equivalent on January 31, 1989, 64 days after the submission was received.
What is the product code of K884924?
The FDA product code is HOF – Burr, Corneal, Manual, a Class I (low risk) device regulated under 21 CFR 886.4350.