Peregrine Pic Minipulator
FDA 510(k) K940392 · Peregrine Surgical , Ltd.
510(k) numberK940392
Submission
- Device name
- Peregrine Pic Minipulator
- Applicant
- Peregrine Surgical , Ltd.
Doylestown, PA, US - Received
- January 26, 1994
- Decision date
- August 23, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KYG – Device, Irrigation, Ocular Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4360
- Specialty
- Ophthalmic
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| K974561 | Moistair Fluid Air Tubing SetKYG · Traditional | American Medical Devices, Inc. | 02/19/1998SE |
| K971173 | ML Disposable Alk TubingKYG · Traditional | Med-Logics, Inc. | 05/22/1997SE |
| K970161 | Hedges Corneal Wetting PakKYG · Traditional | Hedges Cwp, Inc. | 03/25/1997SE |
| K954842 | D.O.R.C. Vfi/Vfe SystemKYG · Traditional | Dutch Ophthalmic USA, Inc. | 04/15/1996SE |
| K945171 | Disposable & Resuable Irrigation/Aspiration HandpieceKYG · Traditional | Boston Surgical Products, Inc. | 02/08/1995SE |
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| 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 Pic Minipulator cleared by the FDA?
Peregrine Pic Minipulator (K940392) received a 510(k) decision of Substantially Equivalent on August 23, 1994, 209 days after the submission was received.
What is the product code of K940392?
The FDA product code is KYG – Device, Irrigation, Ocular Surgery, a Class I (low risk) device regulated under 21 CFR 886.4360.