Peregrine Surgical, LLC.
New Britain, PA, US
Peregrine Surgical, LLC. appears in FDA device records in New Britain, PA. FDA records list 20 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 20 510(k) clearances for Peregrine Surgical, LLC. between 1994 and 2024. The busiest year on record is 1998, with 7. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 3 |
| 1995 | 1 |
| 1998 | 7 |
| 1999 | 1 |
| 2003 | 2 |
| 2006 | 1 |
| 2013 | 3 |
| 2015 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233653 | Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) | MPA | Substantially Equivalent | |
| K151604 | 23ga Chandelier Illuminator, 25ga Chandelier Illuminator | MPA | Substantially Equivalent | |
| K132614 | PEREGRINE CURVED ILLUMINATING LASER PROBE | HQB | Substantially Equivalent | |
| K122997 | 23GA CURVED ILLUMINATING LASER PROBE | HQB | Substantially Equivalent | |
| K122905 | PEREGRINE 23GA CURVED LASER PROBE | HQB | Substantially Equivalent | |
| K061024 | PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60 | HQF | Substantially Equivalent | |
| K031023 | PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10 | HQF | Substantially Equivalent | |
| K024061 | PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00 | GEX | Substantially Equivalent | |
| K990518 | PEREGRINE WET SET, MODEL PD400.00 | FRN | Substantially Equivalent | |
| K981907 | V.F.I.-VISCOUS FLUID INFUSION TUBING SET | MRH | Substantially Equivalent | |
| K980797 | PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR | MPA | Substantially Equivalent | |
| K980530 | PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13 | MPA | Substantially Equivalent | |
| K980400 | PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10 | HQE | Substantially Equivalent | |
| K980399 | PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20 | HQE | Substantially Equivalent | |
| K980027 | PEREGRINE SHIELDED DIFFUSION PROBE | MPA | Substantially Equivalent | |
| K980025 | PEREGRINE TAPERED DIFFUSION PROBE | MPA | Substantially Equivalent | |
| K950529 | PEREGRINE DIFFUSION LIGHT PIPE | HJM | Substantially Equivalent | |
| K940393 | PEREGRINE WIDE ANGLE LIGHT PIPE | HJM | Substantially Equivalent | |
| K940392 | PEREGRINE PIC MINIPULATOR | KYG | Substantially Equivalent | |
| K940391 | PEREGRINE REVERSE CUTTING KNIFE LIGHT PIPE | HQE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2529392 | 1000121498 | Peregrine Surgical, LLC. | 51 Britain Drive, New Britain, PA 18901 US | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HMXCannula, Ophthalmic
- KYGDevice, Irrigation, Ocular Surgery
- MPAEndoilluminator
- HNRForceps, Ophthalmic
- MDMInstrument, Manual, Surgical, General Use
- HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered
- HQFLaser, Ophthalmic
- HQBPhotocoagulator And Accessories
- GEXPowered Laser Surgical Instrument
- FRNPump, Infusion
- MRHPump, Infusion, Ophthalmic
- HNHRing, Ophthalmic (Flieringa)
- HJMTransilluminator, Ac-Powered
- HQCUnit, Phacofragmentation
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2399-2010 | Peregrine 20 GA Endo Ocular Adjustable Laser Probe | Product did not have proper 510(k) clearance | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain