Kirwan Surgical Products, LLC
Marshfield, MA, US
KIRWAN SURGICAL PRODUCTS, LLC. appears in FDA device records in Marshfield, MA. FDA records list 19 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 19 510(k) clearances for Kirwan Surgical Products, LLC between 1990 and 2023. The busiest year on record is 1990, with 3. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 3 |
| 1991 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1996 | 2 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 1 |
| 2003 | 1 |
| 2005 | 1 |
| 2007 | 3 |
| 2010 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231872 | Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020) | GEI | Substantially Equivalent | |
| K100912 | DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE | GXZ | Substantially Equivalent | |
| K070360 | KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601 | LFL | Substantially Equivalent | |
| K060915 | KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS | HCH | Substantially Equivalent | |
| K062659 | KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES | HQP | Substantially Equivalent | |
| K052203 | AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600 | GEI | Substantially Equivalent | |
| K023482 | AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500 | GEI | Substantially Equivalent | |
| K992218 | DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601 | GEI | Substantially Equivalent | |
| K982176 | KIRWAN SURGICAL PRODUCTS, INC. MODEL 28 1500 ELECTROSURGERY GENERATOR | GEI | Substantially Equivalent | |
| K971341 | KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR | GEI | Substantially Equivalent | |
| K965241 | BIPOLAR SUCTION COAGULATOR | GEI | Substantially Equivalent | |
| K962678 | BIPOLAR PENCIL COAGULATOR | GEI | Substantially Equivalent | |
| K960455 | BIPOLAR SUCTION COAGULATOR | GEI | Substantially Equivalent | |
| K930113 | KIRWAN IRRIGATION/ASPIRATION HANDPIECE | HMX | Substantially Equivalent | |
| K925621 | IRRIGATION/ASPIRATION TUBING SET | GAA | Substantially Equivalent | |
| K913514 | ELECTROSURGICAL UNIT CABLE | GEI | Substantially Equivalent | |
| K901896 | ENDOMETRIAL SAMPLER | EJF | Substantially Equivalent | |
| K901897 | ZEPPELIN FORCEPS | HCZ | Substantially Equivalent | |
| K900533 | DISPOSABLE BIPOLAR COAGULATING FORCEPS | GEI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1219619 | 1219619 | KIRWAN SURGICAL PRODUCTS, LLC. | 180 Enterprise Dr, MARSHFIELD, MA 02050 US | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HAMApparatus, Electrosurgical
- GFABlade, Saw, General & Plastic Surgery, Surgical
- EJFBracket, Metal, Orthodontic
- HMXCannula, Ophthalmic
- EMMChisel, Osteotome, Surgical
- HCEClamp, Carotid Artery
- HCHClip, Aneurysm
- JOSElectrode, Electrosurgical
- GXZElectrode, Needle
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GENForceps, General & Plastic Surgery
- HCZForceps, Surgical, Gynecological
- KNAInstrument, Manual, Specialized Obstetric-Gynecologic
- GZXInstrument, Microsurgical
- HAOInstrument, Surgical, Non-Powered
- LFLInstrument, Ultrasonic Surgical
- HXLMallet
- GAANeedle, Aspiration And Injection, Disposable
- HQPUnit, Cautery, Thermal, Battery-Powered
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0660-2025 | 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 procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge. | Potential for the outer stainless-steel tube to break or detach. | Class I | Open, Classified | |
| Z-0659-2025 | 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 other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge. | Potential for the outer stainless-steel tube to break or detach. | Class I | Open, Classified | |
| Z-0658-2025 | 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 procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge. | Potential for the outer stainless-steel tube to break or detach. | Class I | Open, Classified | |
| Z-0657-2025 | 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 instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge. Component: No | Potential for the outer stainless-steel tube to break or detach. | Class I | Open, Classified | |
| Z-0656-2025 | 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 other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge. | Potential for the outer stainless-steel tube to break or detach. | Class I | Open, Classified | |
| Z-0655-2025 | 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 other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge. | Potential for the outer stainless-steel tube to break or detach. | Class I | Open, Classified | |
| Z-0654-2025 | 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 soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge. | Potential for the outer stainless-steel tube to break or detach. | Class I | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain