Company ยท US
Kirwan Surgical Products, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2023. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 18 |
| EJF | Bracket, Metal, Orthodontic | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 |
| GXZ | Electrode, Needle | 1 |
| HCH | Clip, Aneurysm | 1 |
| HCZ | Forceps, Surgical, Gynecological | 1 |
| HMX | Cannula, Ophthalmic | 1 |
| HQP | Unit, Cautery, Thermal, Battery-Powered | 1 |
| LFL | Instrument, Ultrasonic Surgical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 25, 2023 | K231872 | Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (2 Kirwan Surgical Products, LLC | GEI |
| Aug 19, 2010 | K100912 | DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE Kirwan Surgical Products, Inc. | GXZ |
| Aug 7, 2007 | K070360 | KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601 Kirwan Surgical Products, Inc. | LFL |
| Apr 17, 2007 | K060915 | KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS Kirwan Surgical Products, Inc. | HCH |
| Mar 9, 2007 | K062659 | KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES Kirwan Surgical Products, Inc. | HQP |
| Oct 20, 2005 | K052203 | AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600 Kirwan Surgical Products, Inc. | GEI |
| Jan 15, 2003 | K023482 | AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500 Kirwan Surgical Products, Inc. | GEI |
| Jul 30, 1999 | K992218 | DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601 Kirwan Surgical Products, Inc. | GEI |
| Sep 18, 1998 | K982176 | KIRWAN SURGICAL PRODUCTS, INC. MODEL 28 1500 ELECTROSURGERY GENERATOR Kirwan Surgical Products, Inc. | GEI |
| May 22, 1997 | K971341 | KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR Kirwan Surgical Products, Inc. | GEI |
| Feb 28, 1997 | K965241 | BIPOLAR SUCTION COAGULATOR Kirwan Surgical Products, Inc. | GEI |
| Aug 14, 1996 | K962678 | BIPOLAR PENCIL COAGULATOR Kirwan Surgical Products, Inc. | GEI |
| Feb 27, 1996 | K960455 | BIPOLAR SUCTION COAGULATOR Kirwan Surgical Products, Inc. | GEI |
| Feb 17, 1994 | K930113 | KIRWAN IRRIGATION/ASPIRATION HANDPIECE Kirwan Surgical Products, Inc. | HMX |
| May 7, 1993 | K925621 | IRRIGATION/ASPIRATION TUBING SET Kirwan Surgical Products, Inc. | GAA |
| Nov 5, 1991 | K913514 | ELECTROSURGICAL UNIT CABLE Kirwan Surgical Products, Inc. | GEI |
| Aug 13, 1990 | K901896 | ENDOMETRIAL SAMPLER Kirwan Surgical Products, Inc. | EJF |
| Jun 29, 1990 | K901897 | ZEPPELIN FORCEPS Kirwan Surgical Products, Inc. | HCZ |
| Apr 9, 1990 | K900533 | DISPOSABLE BIPOLAR COAGULATING FORCEPS Kirwan Surgical Products, Inc. | GEI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2024 | Kirwan Surgical Products, LLC Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011.
Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue Open, Classified |
GEI | K864402 |
| Dec 16, 2024 | Kirwan Surgical Products, LLC Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979.
Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and othe Open, Classified |
GEI | K864402 |
| Dec 16, 2024 | Kirwan Surgical Products, LLC Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011.
Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue Open, Classified |
GEI | K864402 |
| Dec 16, 2024 | Kirwan Surgical Products, LLC Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226.
The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For Open, Classified |
GEI | K864402 |
| Dec 16, 2024 | Kirwan Surgical Products, LLC Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog Number: AB-7004
The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and o Open, Classified |
GEI | K864402 |
| Dec 16, 2024 | Kirwan Surgical Products, LLC Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L
The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and ot Open, Classified |
GEI | K864402 |
| Dec 16, 2024 | Kirwan Surgical Products, LLC Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011
The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other sof Open, Classified |
GEI | K864402 |