Peregrine Surgical , Ltd.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Peregrine Surgical , Ltd.” (first 1994, latest 2024), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 88 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 3 | 221 |
| 2014 | 0 | — |
| 2015 | 1 | 88 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 265 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Peregrine Surgical , Ltd. took a median 265 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 94 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MPA | Endoilluminator | 6 | 6 |
| HQB | Photocoagulator And Accessories | 3 | 3 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 3 | 3 |
| HJM | Transilluminator, Ac-Powered | 2 | 2 |
| HQF | Laser, Ophthalmic | 2 | 2 |
| FRN | Pump, Infusion | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| KYG | Device, Irrigation, Ocular Surgery | 1 | 1 |
| MRH | Pump, Infusion, Ophthalmic | 1 | 1 |
Review panels
Most recent Peregrine Surgical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233653 | Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) | MPA | 2024-08-05 | 265 |
| K151604 | 23ga Chandelier Illuminator, 25ga Chandelier Illuminator | MPA | 2015-09-11 | 88 |
| K132614 | PEREGRINE CURVED ILLUMINATING LASER PROBE | HQB | 2013-11-14 | 85 |
| K122997 | 23GA CURVED ILLUMINATING LASER PROBE | HQB | 2013-06-26 | 272 |
| K122905 | PEREGRINE 23GA CURVED LASER PROBE | HQB | 2013-04-30 | 221 |
| K061024 | PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60 | HQF | 2006-06-21 | 69 |
| K031023 | PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10 | HQF | 2003-06-27 | 88 |
| K024061 | PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00 | GEX | 2003-03-07 | 88 |
| K990518 | PEREGRINE WET SET, MODEL PD400.00 | FRN | 1999-03-25 | 35 |
| K981907 | V.F.I.-VISCOUS FLUID INFUSION TUBING SET | MRH | 1998-08-04 | 64 |
10 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2010-07-19.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Peregrine Surgical , Ltd. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances are listed under Peregrine Surgical , Ltd.?
FDA lists 20 510(k) clearances under the applicant name “Peregrine Surgical , Ltd.” (first 1994, latest 2024), across 9 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Peregrine Surgical , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Peregrine Surgical , Ltd. is 88 days.
Which FDA product codes appear under Peregrine Surgical , Ltd.?
The most frequent FDA product codes under this applicant name are MPA (Endoilluminator, 6); HQB (Photocoagulator And Accessories, 3); HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered, 3).
Next steps
- See all 20 Peregrine Surgical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MPA, Peregrine Surgical , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.