Kirwan Surgical Products, Inc. Model 28 1500 Electrosurgery Generator
FDA 510(k) K982176 · Kirwan Surgical Products, Inc.
510(k) numberK982176
Submission
- Device name
- Kirwan Surgical Products, Inc. Model 28 1500 Electrosurgery Generator
- Applicant
- Kirwan Surgical Products, Inc.
Marshfield, MA, US - Received
- June 22, 1998
- Decision date
- September 18, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code GEI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254185 | Potenza PrimeGEI · Traditional | Jeisys Medical Incorporated | 09/11/2026SE |
| K262364 | Ellian Enigma RF DeviceGEI · Traditional | Ellian Corp | 09/02/2026SE |
| K253859 | Scarlet Pro (Scarlet Pro)GEI · Traditional | VIOL Co., Ltd. | 08/27/2026SE |
| K252535 | Inno-Switch Laparoscopic InstrumentsGEI · Traditional | Taiwan Surgical Corporation | 08/25/2026SE |
| K261179 | AlphaTriPart - Monopolar MIC InstrumentsGEI · Traditional | Gimmi GmbH | 07/22/2026SE |
| K253504 | VolnewmerGEI · Traditional | Classys, Inc. | 07/13/2026SE |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional | Olympus Medical Systems Corp. | 07/01/2026SE |
| K253484 | Lutronic GeniusGEI · Traditional | Cynosure Lutronic Technology Corporation | 06/29/2026SE |
| K251492 | Irrigation Tubing Bipolar Cord SetGEI · Traditional | New Deantronics Taiwan , Ltd. | 06/29/2026SE |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingGEI · Traditional | Stryker Sustainability Solutions | 06/18/2026SE |
More from Stryker Sustainability Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K231872 | Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module…GEI · Traditional | 08/25/2023SE |
| K100912 | Disposable Nerve Stimulating Probe, Bipolar Concentric, Disposable Nerve Stimulator…GXZ · Traditional | 08/19/2010SE |
| K070360 | Kirwan Disposable 23KHZ Manifold Tubing, 40-3600, & 36KHZ Manifold Tubing, 40-3601LFL · Traditional | 08/07/2007SE |
| K060915 | Kirwan L-Aneurysm Clips and Applier, Kirwan Yasargil-Type Aneurysm Clips and AppliersHCH · Traditional | 04/17/2007SE |
| K062659 | Kirwan Disposable Battery-Powered Cautery, Model 41-61XX SeriesHQP · Traditional | 03/09/2007SE |
| K052203 | Aura 70 Watt Bipolar Electrosurgical Coagulators, Models 28-2000 and 28-2600GEI · Traditional | 10/20/2005SE |
| K023482 | Aura 20 Bipolar Electrosurgical Coagulator, Model 26-2500GEI · Traditional | 01/15/2003SE |
| K992218 | Disposable Irrigation Bipolar Cord Assembly for Malis System Cmc-Ii, Model 10-4601GEI · Traditional | 07/30/1999SE |
| K971341 | Kirwan Model 28 1000 Bipolar CoagulatorGEI · Traditional | 05/22/1997SE |
| K965241 | Bipolar Suction CoagulatorGEI · Traditional | 02/28/1997SE |
Questions and answers
When was Kirwan Surgical Products, Inc. Model 28 1500 Electrosurgery Generator cleared by the FDA?
Kirwan Surgical Products, Inc. Model 28 1500 Electrosurgery Generator (K982176) received a 510(k) decision of Substantially Equivalent on September 18, 1998, 88 days after the submission was received.
What is the product code of K982176?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.