Kirwan Surgical Products, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Kirwan Surgical Products, Inc.” (first 1990, latest 2023), across 9 product codes in 5 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 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 60 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Kirwan Surgical Products, Inc. took a median 60 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 11 | 11 |
| EJF | Bracket, Metal, Orthodontic | 1 | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 | 1 |
| GXZ | Electrode, Needle | 1 | 1 |
| HCH | Clip, Aneurysm | 1 | 1 |
| HCZ | Forceps, Surgical, Gynecological | 1 | 1 |
| HMX | Cannula, Ophthalmic | 1 | 1 |
| HQP | Unit, Cautery, Thermal, Battery-Powered | 1 | 1 |
| LFL | Instrument, Ultrasonic Surgical | 1 | 1 |
Review panels
- General and Plastic Surgery (13)
- Neurology (2)
- Ophthalmic (2)
- Dental (1)
- Obstetrics and Gynecology (1)
Most recent Kirwan Surgical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231872 | Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020) | GEI | 2023-08-25 | 60 |
| K100912 | DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE | GXZ | 2010-08-19 | 140 |
| K070360 | KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601 | LFL | 2007-08-07 | 181 |
| K060915 | KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS | HCH | 2007-04-17 | 378 |
| K062659 | KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES | HQP | 2007-03-09 | 183 |
| K052203 | AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600 | GEI | 2005-10-20 | 69 |
| K023482 | AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500 | GEI | 2003-01-15 | 90 |
| K992218 | DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601 | GEI | 1999-07-30 | 29 |
| K982176 | KIRWAN SURGICAL PRODUCTS, INC. MODEL 28 1500 ELECTROSURGERY GENERATOR | GEI | 1998-09-18 | 88 |
| K971341 | KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR | GEI | 1997-05-22 | 42 |
9 earlier clearances. See the full list in Caduvo.
Recalls
7 product recalls in 1 recall events; 7 initiated in the last five years. Most recent: 2024-11-14.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Kirwan Surgical Products, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Kirwan Surgical Products, Inc.” (first 1990, latest 2023), across 9 product codes in 5 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 Kirwan Surgical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kirwan Surgical Products, Inc. is 88 days.
Which FDA product codes appear under Kirwan Surgical Products, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 11); EJF (Bracket, Metal, Orthodontic, 1); GAA (Needle, Aspiration And Injection, Disposable, 1).
Next steps
- See all 19 Kirwan Surgical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Kirwan Surgical Products, Inc.'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.