Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kirwan Surgical Products, Inc. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
378 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100912 | DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISP | Kirwan Surgical Products, Inc. | 2010-08-19 | 140 | 0 |
| K070360 | KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MA | Kirwan Surgical Products, Inc. | 2007-08-07 | 181 | 0 |
| K060915 | KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE AN | Kirwan Surgical Products, Inc. | 2007-04-17 | 378 | 0 |
| K062659 | KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SER | Kirwan Surgical Products, Inc. | 2007-03-09 | 183 | 0 |
| K052203 | AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28- | Kirwan Surgical Products, Inc. | 2005-10-20 | 69 | 0 |
| K023482 | AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500 | Kirwan Surgical Products, Inc. | 2003-01-15 | 90 | 0 |
| K992218 | DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM | Kirwan Surgical Products, Inc. | 1999-07-30 | 29 | 0 |
| K982176 | KIRWAN SURGICAL PRODUCTS, INC. MODEL 28 1500 ELECTROSURGERY | Kirwan Surgical Products, Inc. | 1998-09-18 | 88 | 0 |
| K971341 | KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR | Kirwan Surgical Products, Inc. | 1997-05-22 | 42 | 0 |
| K965241 | BIPOLAR SUCTION COAGULATOR | Kirwan Surgical Products, Inc. | 1997-02-28 | 79 | 0 |
| K962678 | BIPOLAR PENCIL COAGULATOR | Kirwan Surgical Products, Inc. | 1996-08-14 | 35 | 0 |
| K960455 | BIPOLAR SUCTION COAGULATOR | Kirwan Surgical Products, Inc. | 1996-02-27 | 28 | 0 |
| K930113 | KIRWAN IRRIGATION/ASPIRATION HANDPIECE | Kirwan Surgical Products, Inc. | 1994-02-17 | 402 | 0 |
| K925621 | IRRIGATION/ASPIRATION TUBING SET | Kirwan Surgical Products, Inc. | 1993-05-07 | 182 | 0 |
| K913514 | ELECTROSURGICAL UNIT CABLE | Kirwan Surgical Products, Inc. | 1991-11-05 | 90 | 0 |
| K901896 | ENDOMETRIAL SAMPLER | Kirwan Surgical Products, Inc. | 1990-08-13 | 110 | 0 |
| K901897 | ZEPPELIN FORCEPS | Kirwan Surgical Products, Inc. | 1990-06-29 | 65 | 0 |
| K900533 | DISPOSABLE BIPOLAR COAGULATING FORCEPS | Kirwan Surgical Products, Inc. | 1990-04-09 | 76 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda