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Sign in to claim this brandKIRWAN SURGICAL PRODUCTS LLC
United States·US-MF-000008222
Last updated May 26, 2026
What KIRWAN SURGICAL PRODUCTS LLC makes
Kirwan Surgical Products LLC manufactures reusable and single-use electrosurgical handpieces and electrodes for open-surgery procedures, including bipolar and monopolar designs. Their portfolio also includes reusable and single-use electrical connection cables for medical devices, as well as electrosurgical system generators and reusable surgical irrigation/aspiration handpieces.
The company’s devices are classified under FDA categories Class I, Class II, Class IIb, and Unclassified (U), and are listed in the EUDAMED and FDA’s Unique Device Identifier (UDI) databases. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Kirwan Surgical Products LLC manufacture?
Kirwan Surgical Products LLC specializes in electrosurgical tools for open-surgery procedures. Their product range includes reusable and single-use bipolar and monopolar electrosurgical handpieces and electrodes, reusable and single-use electrical connection cables, electrosurgical system generators, and reusable surgical irrigation/aspiration handpieces. These devices are designed to assist in precise tissue cutting, coagulation, and fluid management during surgical operations.
Where is Kirwan Surgical Products LLC based?
Kirwan Surgical Products LLC is headquartered in the United States. The company’s location is relevant for regulatory compliance, as it operates under U.S. FDA guidelines and may also engage with global markets where its devices are authorized for use.
Which regulatory databases list Kirwan Surgical Products LLC’s devices?
Kirwan Surgical Products LLC’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry, and the FDA’s Unique Device Identifier (UDI) database in the United States. Listing in these databases helps ensure transparency and traceability of their products for regulatory and market surveillance purposes.
How are Kirwan Surgical Products LLC’s devices classified under FDA regulations?
Kirwan Surgical Products LLC’s devices fall into multiple FDA classification categories: Class I (generally low-risk), Class II (moderate risk with special controls), Class IIb (a subset of Class II with additional regulatory oversight), and Unclassified (U) devices. The classification depends on factors like the device’s intended use, risk level, and potential impact on patient safety, influencing the regulatory pathway each product must follow for authorization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 180, Enterprise Drive, Marshfield, United States
- Website
- www.ksp.com
- —
- —
- [email protected]
- Phone
- 781-834-9500
- PRRC Contact
- Linda Varroso
- EUDAMED SRN
- US-MF-000008222
- FDA FEI Number
- —
- DUNS Number
- 046355210
Catalogue (2076)
Page 5 of 42| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Kirwan | 10-2604AUS | FDA UDI | Class II | Active |
| Kirwan | 15-5302S | FDA UDI | Class II | Active |
| Kirwan | 19-2004C | FDA UDI | Class II | Active |
| Kirwan | 23-1411AUS | FDA UDI | Class II | Active |
| Kirwan | 10-2604AUS | FDA UDI | Class II | Active |
| Kirwan | 24-1461EAUS | FDA UDI | Class II | Active |
| Weck | 392036 | FDA UDI | Class II | Unknown |
| Kirwan | 10-5405NSS | FDA UDI | Class II | Active |
| Kirwan | 19-5044AUIR | FDA UDI | Class II | Unknown |
| Kirwan | 21-1426AUS | FDA UDI | Class II | Active |
| Kirwan | 20-1616AUS | FDA UDI | Class II | Active |
| Kirwan | 20-1421NSS | FDA UDI | Class II | Active |
| Kirwan (Distributor Gyrus ACMI) | 13-1502 | FDA UDI | Class II | Active |
| Kirwan | 10-1299AUS | FDA UDI | Class II | Active |
| Kirwan | 24-1434EAU | FDA UDI | Class II | Active |
| Kirwan | 12-1437AUS | FDA UDI | Class II | Active |
| Kirwan | 10-2402AUS | FDA UDI | Class II | Active |
| Kirwan | 20-1617AUS | FDA UDI | Class II | Active |
| Kirwan | 30-3014S | FDA UDI | Class I | Active |
| Kirwan | 20-1620AUS | FDA UDI | Class II | Active |
| Kirwan | 20-1618AUS | FDA UDI | Class II | Active |
| Kirwan | 12-1437AUS | FDA UDI | Class II | Active |
| Kirwan | 12-1400AUS | FDA UDI | Class II | Active |
| Kirwan | 20-1416NSS | FDA UDI | Class II | Active |
| Kirwan | 28-2600PS | FDA UDI | Class II | Active |
| Kirwan | 12-1130AUS | FDA UDI | Class II | Active |
| Kirwan | 10-1299AUS | FDA UDI | Class II | Active |
| Kirwan | 10-3215NSS | FDA UDI | Class II | Active |
| Kirwan | 10-5602NSS | FDA UDI | Class II | Active |
| Kirwan | 20-1620AUS | FDA UDI | Class II | Active |
| Kirwan | 12-1635AUS | FDA UDI | Class II | Active |
| Kirwan | 21-1425AUS | FDA UDI | Class II | Active |
| Weck | 394237 | FDA UDI | Class II | Unknown |
| Kirwan | 19-2042AU | FDA UDI | Class II | Active |
| Kirwan | 10-2404AUS | FDA UDI | Class II | Active |
| Kirwan | 10-9070 | FDA UDI | Class II | Active |
| Kirwan | 20-1420AUS | FDA UDI | Class II | Active |
| Kirwan | 10-5404AUS | FDA UDI | Class II | Active |
| Kirwan | 10-2404AUS | FDA UDI | Class II | Active |
| Kirwan | 10-5403NSS | FDA UDI | Class II | Active |
| Kirwan | 12-1130AUS | FDA UDI | Class II | Active |
| Kirwan | 12-1432AUS | FDA UDI | Class II | Active |
| Kirwan | 12-1140AUS | FDA UDI | Class II | Active |
| Kirwan | 19-5036AU | FDA UDI | Class II | Unknown |
| Kirwan | 21-1422AUS | FDA UDI | Class II | Active |
| Kirwan | 19-2024AU | FDA UDI | Class II | Active |
| Kirwan | 21-1427AUS | FDA UDI | Class II | Active |
| Kirwan | 11-1403AUS | FDA UDI | Class II | Active |
| Kirwan | 15-1435AUS | FDA UDI | Class II | Active |
| Kirwan | 10-5602NSS | FDA UDI | Class II | Active |
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FDA Recalls (7)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Kirwan Surgical Products LLC has seven recall records, all initiated on November 14, 2024. The records are marked as either open or classified, with the sole reason stated as the potential for the outer stainless-steel tube to break or detach.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Nov 14, 2024 | Z-0659-2025 | — | open, classified | Potential for the outer stainless-steel tube to break or detach. |
| Nov 14, 2024 | Z-0655-2025 | — | open, classified | Potential for the outer stainless-steel tube to break or detach. |
| Nov 14, 2024 | Z-0658-2025 | — | open, classified | Potential for the outer stainless-steel tube to break or detach. |
| Nov 14, 2024 | Z-0657-2025 | — | open, classified | Potential for the outer stainless-steel tube to break or detach. |
| Nov 14, 2024 | Z-0656-2025 | — | open, classified | Potential for the outer stainless-steel tube to break or detach. |
| Nov 14, 2024 | Z-0660-2025 | — | open, classified | Potential for the outer stainless-steel tube to break or detach. |
| Nov 14, 2024 | Z-0654-2025 | — | open, classified | Potential for the outer stainless-steel tube to break or detach. |