Data / Medical devices / United States / Peregrine Surgical, LLC.
Peregrine Surgical, LLC.: FDA-registered device maker in New Britain, PA, United States, 11 510(k) clearances
Peregrine Surgical, LLC. is registered with the FDA (registration 2529392) in New Britain, PA, United States. It lists 11 device types. The FDA files 11 510(k) clearances under its listings, the newest dated August 5, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2529392
- FEI number
- 1000121498
- Address
- 51 Britain Drive, New Britain, PA, United States, 18901
- Owner or operator
- PEREGRINE SURGICAL LLC (9002261)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- June 21, 2004
- Registered through
- 2026
- Brand names listed
- 3269.M04-00,3269.M05-00,3269.M06-00, Acculite Endo Probe - EndoOcular Illuminating Probe, Aspirating Laser Probes, BL5234,BL5235, BL5293ASP,BLS5293ASPH,GA-0040013,GA-0040039,GA-0040000,GA-0040026, BL5295L,BL5295LC,GA-0040003,GA-0040004,GA-0040005,GA-0040006,GA-0040010,GA-0040011,GA-0040087,GA-0040089,GA-0040073, BL5723 23GA Light Pipe, BL5725 25GA Light Pipe and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Ophthalmic | HMX | 1 | Manufacturer | accessdata.fda.gov |
| Device, Irrigation, Ocular Surgery | KYG | 1 | Manufacturer | accessdata.fda.gov |
| Endoilluminator | MPA | 2 | Manufacturer | accessdata.fda.gov |
| Forceps, Ophthalmic | HNR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | HQE | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Laser, Ophthalmic | HQF | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Photocoagulator And Accessories | HQB | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Ring, Ophthalmic (Flieringa) | HNH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Unit, Phacofragmentation | HQC | 2 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 5, 2024 | 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 | Peregrine Surgical, LLC | accessdata.fda.gov |
| September 11, 2015 | K151604 | 23ga Chandelier Illuminator, 25ga Chandelier Illuminator | MPA | Substantially Equivalent | Peregrine Surgical , Ltd. | accessdata.fda.gov |
| November 14, 2013 | K132614 | PEREGRINE CURVED ILLUMINATING LASER PROBE | HQB | Substantially Equivalent | Peregrine Surgical , Ltd. | accessdata.fda.gov |
| June 26, 2013 | K122997 | 23GA CURVED ILLUMINATING LASER PROBE | HQB | Substantially Equivalent | Peregrine Surgical , Ltd. | accessdata.fda.gov |
| April 30, 2013 | K122905 | PEREGRINE 23GA CURVED LASER PROBE | HQB | Substantially Equivalent | Peregrine Surgical , Ltd. | accessdata.fda.gov |
| June 21, 2006 | K061024 | PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60 | HQF | Substantially Equivalent | Peregrine Surgical , Ltd. | accessdata.fda.gov |
| June 27, 2003 | K031023 | PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10 | HQF | Substantially Equivalent | Peregrine Surgical , Ltd. | accessdata.fda.gov |
| March 7, 2003 | K024061 | PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00 | GEX | Substantially Equivalent | Peregrine Surgical , Ltd. | accessdata.fda.gov |
| May 19, 1998 | K980797 | PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR | MPA | Substantially Equivalent | Peregrine Surgical , Ltd. | accessdata.fda.gov |
| May 12, 1998 | K980530 | PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13 | MPA | Substantially Equivalent | Peregrine Surgical , Ltd. | accessdata.fda.gov |
| March 31, 1998 | K980025 | PEREGRINE TAPERED DIFFUSION PROBE | MPA | Substantially Equivalent | Peregrine Surgical , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 19, 2010 | 56271 | Not yet classified | Terminated | Peregrine 20 GA Endo Ocular Adjustable Laser Probe | Product did not have proper 510(k) clearance | accessdata.fda.gov |
Compare with other makers
- All makers of Laser, Ophthalmic
- All makers of Forceps, Ophthalmic
- All makers of Endoilluminator
- All makers of Instrument, Vitreous Aspiration And Cutting, Ac-Powered
- All makers of Device, Irrigation, Ocular Surgery
- All makers of Powered Laser Surgical Instrument
Updated August 5, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.