Visitec Eye Speculum
FDA 510(k) K843196 · Visitec Co.
510(k) numberK843196
Submission
- Device name
- Visitec Eye Speculum
- Applicant
- Visitec Co.
Mchenry, IL, US - Received
- August 14, 1984
- Decision date
- October 5, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HNC – Specula, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HNC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022836 | Stephens Disposable SpeculumHNC · Traditional | Stephens Instruments | 11/01/2002SE |
| K981235 | OculostatHNC · Traditional | Laser Center Dev. Corp. | 07/15/1998SE |
| K964289 | Eye Fixation SpeculumHNC · Traditional | Eyefix, Inc. | 12/17/1996SE |
| K863989 | Thornton Titanium Speculum (Modified Barraquer)HNC · Traditional | Keeler Instruments, Inc. | 10/31/1986SE |
| K863664 | Ophthalmic Surgical SpeculumHNC · Traditional | Myocure, Inc. | 09/25/1986SE |
| K830430 | Eyelid SpeculumHNC · Traditional | Douglas C. Mckee & Co. | 06/10/1983SE |
| K801969 | Asnis Guided Screw SystemsHNC · Traditional | Howmedica Corp. | 08/27/1980SE |
| K760849 | Feldstein Blepharostomy Clip SquareHNC · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 11/02/1976SE |
| K760848 | Feldstein Blepharoplasty Clip RectanguHNC · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 11/02/1976SE |
| K760847 | Feldstein Blepharoplasty Clip Sharp PHNC · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 11/02/1976SE |
More from V. Mueller O.V. Baxter Healthcare Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K953394 | Visitec Collar Button Catheter {Griffiths}LZU · Traditional | 10/12/1995SE |
| K945114 | Visitec Scleral PlugLXP · Traditional | 02/23/1995SE |
| K945738 | Visiflex Ophthalmic Surgical Incise DrapeHMT · Traditional | 02/14/1995SE |
| K945172 | Visitec Silicone Retinal Implants/ExplantsHQX · Traditional | 01/17/1995SE |
| 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 Visitec Eye Speculum cleared by the FDA?
Visitec Eye Speculum (K843196) received a 510(k) decision of Substantially Equivalent on October 5, 1984, 52 days after the submission was received.
What is the product code of K843196?
The FDA product code is HNC – Specula, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.