Fiberoptic Illuminated Instruments
FDA 510(k) K934269 · Visitec Co.
510(k) numberK934269
Submission
- Device name
- Fiberoptic Illuminated Instruments
- Applicant
- Visitec Co.
Sarasota, FL, US - Received
- August 31, 1993
- Decision date
- May 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HJM – Transilluminator, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1945
- Specialty
- Ophthalmic
Other 510(k)s with product code HJM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972506 | Infinitech Bullet Endo Illuminated Pick ManipulatorHJM · Traditional | Infinitech, Inc. | 10/01/1997SE |
| K950529 | Peregrine Diffusion Light PipeHJM · Traditional | Peregrine Surgical , Ltd. | 06/07/1995SE |
| K945877 | Weco Endoscopic Systems with Fiber Optic LightHJM · Traditional | Wells Johnson Co. | 03/02/1995SE |
| K931072 | HGM Illuminating/Aspirating Endoocular ProbeHJM · Traditional | Hgm, Inc. | 11/10/1994SE |
| K933445 | DPS 100 Multiport Illumination System (Mis)HJM · Traditional | Storz Instrument Co. | 09/23/1994SE |
| K940393 | Peregrine Wide Angle Light PipeHJM · Traditional | Peregrine Surgical , Ltd. | 09/02/1994SE |
| K913273 | Drolite(Tm) Light SourceHJM · Traditional | Vision Medical, Inc. | 12/04/1991SE |
| K894513 | Diathron(R) Diathermy UnitHJM · Traditional | Intl. Ophthalmic Industries Corp. | 10/31/1989SE |
| K893170 | Vista Finoff Transilluminator (Ac-Powered)HJM · Traditional | Keeler Instruments, Inc. | 06/05/1989SE |
| K812949 | Rmi Transilluminator, Model 292HJM · Traditional | Radiation Measurements, Inc. | 12/02/1981SE |
More from Radiation Measurements, Inc.
| 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 |
| 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 Fiberoptic Illuminated Instruments cleared by the FDA?
Fiberoptic Illuminated Instruments (K934269) received a 510(k) decision of Substantially Equivalent on May 17, 1994, 259 days after the submission was received.
What is the product code of K934269?
The FDA product code is HJM – Transilluminator, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1945.