Weco Endoscopic Systems with Fiber Optic Light
FDA 510(k) K945877 · Wells Johnson Co.
510(k) numberK945877
Submission
- Device name
- Weco Endoscopic Systems with Fiber Optic Light
- Applicant
- Wells Johnson Co.
Tucson, AZ, US - Received
- December 1, 1994
- Decision date
- March 2, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
| K934269 | Fiberoptic Illuminated InstrumentsHJM · Traditional | Visitec Co. | 05/17/1994SE |
| 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 |
|---|---|---|
| K991437 | Wells Johnson Infusion System, Model 20-6000-00FRN · Traditional | 08/30/1999SE |
| K984448 | Bircoll Balloon DissectorFZW · Traditional | 01/28/1999SE |
| K971580 | Uas Ultrasonic Aspirator SystemLFL · Traditional | 12/09/1997SE |
| K945876 | Weco Endoscopic System with Fiber Optic LightEQH · Traditional | 12/04/1995SE |
| K945500 | Wells Johnson Fixation SystemJEY · Traditional | 09/21/1995SE |
| K951519 | Weco Endoscopic System with Fiber Optic LightFWL · Traditional | 06/14/1995SE |
| K945805 | Wells Johnson Weco Monopolar/Frazier Suction ProbeGEI · Traditional | 12/13/1994SE |
| K854068 | External Mechanical Fastener · Traditional | 11/22/1985SE |
| K843188 | Wells Johnson Co. Chaj-Chir-Suction TipJOL · Traditional | 09/20/1984SE |
| K832521 | Plastic Suction TipsGEA · Traditional | 10/20/1983SE |
Questions and answers
When was Weco Endoscopic Systems with Fiber Optic Light cleared by the FDA?
Weco Endoscopic Systems with Fiber Optic Light (K945877) received a 510(k) decision of Substantially Equivalent on March 2, 1995, 91 days after the submission was received.
What is the product code of K945877?
The FDA product code is HJM – Transilluminator, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1945.