Data / Medical devices / United States / Kirwan Surgical Products, LLC.
Kirwan Surgical Products, LLC.: FDA-registered device maker in Marshfield, MA, United States, 21 510(k) clearances
Kirwan Surgical Products, LLC. is registered with the FDA (registration 1219619) in Marshfield, MA, United States. It lists 14 device types. The FDA files 21 510(k) clearances under its listings, the newest dated August 19, 2010. 1 recall event names it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1219619
- Address
- 180 Enterprise Dr, Marshfield, MA, United States, 02050
- Owner or operator
- KIRWAN SURGICAL PRODUCTS LLC (1219619)
- Roles
- Manufacturer
- First device listed
- December 31, 1992
- Registered through
- 2027
- Brand names listed
- ;REAMING FORCESP, AURA 70 WATT BIPOLAR ELE, Aura 20 Watt Bipolar Electrosurgical Coagulator, Model 26-2500, Bipolar Disposable Cord, Bipolar Intraocular Probe, Bipolar Pencil, Bipolar Reusable Cord, Bipolar Reusable Forceps and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Electrosurgical | HAM | 2 | Manufacturer | accessdata.fda.gov |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | 1 | Manufacturer | accessdata.fda.gov |
| Cannula, Ophthalmic | HMX | 1 | Manufacturer | accessdata.fda.gov |
| Chisel, Osteotome, Surgical | EMM | 1 | Manufacturer | accessdata.fda.gov |
| Clamp, Carotid Artery | HCE | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Electrosurgical | JOS | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Needle | GXZ | 2 | Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Specialized Obstetric-Gynecologic | KNA | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Microsurgical | GZX | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Non-Powered | HAO | 1 | Manufacturer | accessdata.fda.gov |
| Mallet | HXL | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Cautery, Thermal, Battery-Powered | HQP | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 19, 2010 | K100912 | DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE | GXZ | Substantially Equivalent | Kirwan Surgical Products, Inc. | accessdata.fda.gov |
| March 9, 2007 | K062659 | KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES | HQP | Substantially Equivalent | Kirwan Surgical Products, Inc. | accessdata.fda.gov |
| October 20, 2005 | K052203 | AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600 | GEI | Substantially Equivalent | Kirwan Surgical Products, Inc. | accessdata.fda.gov |
| January 15, 2003 | K023482 | AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500 | GEI | Substantially Equivalent | Kirwan Surgical Products, Inc. | accessdata.fda.gov |
| July 30, 1999 | K992218 | DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601 | GEI | Substantially Equivalent | Kirwan Surgical Products, Inc. | accessdata.fda.gov |
| August 14, 1996 | K962678 | BIPOLAR PENCIL COAGULATOR | GEI | Substantially Equivalent | Kirwan Surgical Products, Inc. | accessdata.fda.gov |
| February 27, 1996 | K960455 | BIPOLAR SUCTION COAGULATOR | GEI | Substantially Equivalent | Kirwan Surgical Products, Inc. | accessdata.fda.gov |
| February 17, 1994 | K930113 | KIRWAN IRRIGATION/ASPIRATION HANDPIECE | HMX | Substantially Equivalent | Kirwan Surgical Products, Inc. | accessdata.fda.gov |
| November 5, 1991 | K913514 | ELECTROSURGICAL UNIT CABLE | GEI | Substantially Equivalent | Kirwan Surgical Products, Inc. | accessdata.fda.gov |
| April 9, 1990 | K900533 | DISPOSABLE BIPOLAR COAGULATING FORCEPS | GEI | Substantially Equivalent | Kirwan Surgical Products, Inc. | accessdata.fda.gov |
| September 15, 1989 | K895337 | ELECTROSURGICAL COAGULATION SUCTION TUBE | HAM | Substantially Equivalent | New England Surgical Instrument Corp. | accessdata.fda.gov |
| September 15, 1989 | K895331 | ELECTROSURGICAL ELECTRODE | JOS | Substantially Equivalent | New England Surgical Instrument Corp. | accessdata.fda.gov |
| September 13, 1988 | K883396 | HANDSWITCHING MONOPOLAR PENCIL | GEI | Substantially Equivalent | New England Surgical Instrument Corp. | accessdata.fda.gov |
| June 26, 1987 | K872271 | VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPS | GEN | Substantially Equivalent | New England Surgical Instrument Corp. | accessdata.fda.gov |
| February 4, 1987 | K864771 | CHUCK HANDLE | GEI | Substantially Equivalent | New England Surgical Instrument Corp. | accessdata.fda.gov |
| January 20, 1987 | K864402 | BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBE | GEI | Substantially Equivalent | New England Surgical Instrument Corp. | accessdata.fda.gov |
| May 30, 1986 | K861876 | CRANIO BLADES AND WIRE PASS DRILL | GFA | Substantially Equivalent | New England Surgical Instrument Corp. | accessdata.fda.gov |
| January 16, 1985 | K844823 | MICROINFERTILITY FORCEPS, TITANIUM | KNA | Substantially Equivalent | Precision Surgical Instrument, Inc. | accessdata.fda.gov |
| June 2, 1983 | K831236 | BIPOLAR CARD | GEI | Substantially Equivalent | New England Surgical Instrument Corp. | accessdata.fda.gov |
| September 24, 1981 | K811821 | CAROTID ARTERY CLAMP & TOOLS | HCE | Substantially Equivalent | New England Surgical Instrument Corp. | accessdata.fda.gov |
| July 28, 1981 | K811820 | BIPOLAR COAGULATING FORCEPS | GEI | Substantially Equivalent | New England Surgical Instrument Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 14, 2024 | 95753 | Class I | Ongoing | 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. | Potential for the outer stainless-steel tube to break or detach. | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Surgical, Non-Powered
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Instrument, Manual, Specialized Obstetric-Gynecologic
- All makers of Instrument, Microsurgical
- All makers of Blade, Saw, General & Plastic Surgery, Surgical
Updated December 16, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.