Peregrine Wide Angle Light Pipe
FDA 510(k) K940393 · Peregrine Surgical , Ltd.
510(k) numberK940393
Submission
- Device name
- Peregrine Wide Angle Light Pipe
- Applicant
- Peregrine Surgical , Ltd.
Doylestown, PA, US - Received
- January 26, 1994
- Decision date
- September 2, 1994
- 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 |
| 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 |
| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K233653 | Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00)…MPA · Traditional | 08/05/2024SE |
| K151604 | 23ga Chandelier Illuminator, 25ga Chandelier IlluminatorMPA · Traditional | 09/11/2015SE |
| K132614 | Peregrine Curved Illuminating Laser ProbeHQB · Special | 11/14/2013SE |
| K122997 | 23GA Curved Illuminating Laser ProbeHQB · Special | 06/26/2013SE |
| K122905 | Peregrine 23GA Curved Laser ProbeHQB · Special | 04/30/2013SE |
| K061024 | Peregrine Soft Tip Aspirating Laser Probe, Model PD720.60HQF · Traditional | 06/21/2006SE |
| K031023 | Peregrine Illuminating Laser Probe Model PD600.10HQF · Traditional | 06/27/2003SE |
| K024061 | Peregrine Straight Laser Probe, Model PD6000.00GEX · Traditional | 03/07/2003SE |
| K990518 | Peregrine Wet Set, Model PD400.00FRN · Traditional | 03/25/1999SE |
| K981907 | V.F.I.-Viscous Fluid Infusion Tubing SetMRH · Traditional | 08/04/1998SE |
Questions and answers
When was Peregrine Wide Angle Light Pipe cleared by the FDA?
Peregrine Wide Angle Light Pipe (K940393) received a 510(k) decision of Substantially Equivalent on September 2, 1994, 219 days after the submission was received.
What is the product code of K940393?
The FDA product code is HJM – Transilluminator, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1945.