Visiflex Ophthalmic Surgical Incise Drape
FDA 510(k) K945738 · Visitec Co.
510(k) numberK945738
Submission
- Device name
- Visiflex Ophthalmic Surgical Incise Drape
- Applicant
- Visitec Co.
Sarasota, FL, US - Received
- November 23, 1994
- Decision date
- February 14, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HMT – Drape, Patient, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HMT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K905460 | Sterile Disposable Drape/Ophthalmic SurgeryHMT · Traditional | Angiosystems, Inc. | 02/06/1991SE |
| K872620 | Solos Eyesite DrapesHMT · Traditional | Solos Ophthalmology | 07/31/1987SE |
| K871706 | Optha PrepHMT · Traditional | Treace Medical, Inc. | 05/18/1987SE |
| K854613 | Surgical Drapes, OphthalminHMT · Traditional | Charles Atkins & Co. | 02/13/1986SE |
| K831340 | Drain-R-Drape(EyeHMT · Traditional | Sur-Tech, Inc. | 06/08/1983SE |
| K830822 | Eye DrapeHMT · Traditional | CooperVision, Inc. | 04/06/1983SE |
More from CooperVision, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K953394 | Visitec Collar Button Catheter {Griffiths}LZU · Traditional | 10/12/1995SE |
| K945114 | Visitec Scleral PlugLXP · Traditional | 02/23/1995SE |
| 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 |
| K923645 | Visitec Aspirating SyringeFMF · Traditional | 09/30/1992SE |
Questions and answers
When was Visiflex Ophthalmic Surgical Incise Drape cleared by the FDA?
Visiflex Ophthalmic Surgical Incise Drape (K945738) received a 510(k) decision of Substantially Equivalent on February 14, 1995, 83 days after the submission was received.
What is the product code of K945738?
The FDA product code is HMT – Drape, Patient, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 878.4370.