Beamer Argon Snare Probe
FDA 510(k) K081580 · Conmed Corporation
510(k) numberK081580
Submission
- Device name
- Beamer Argon Snare Probe
- Applicant
- Conmed Corporation
Billerica, MA, US - Received
- June 5, 2008
- Decision date
- June 19, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
|---|---|---|
| K261363 | Y-Knotless Flex AnchorsMBI · Special | 05/13/2026SE |
| K253763 | Y-Knotless Flex AnchorsMBI · Special | 01/29/2026SE |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation KitMAI · Special | 10/15/2025SE |
| K251530 | CONMED Argo Knotless® AnchorMBI · Special | 06/18/2025SE |
| K250395 | BioBrace ® RC Delivery SystemORQ · Traditional | 04/07/2025SE |
| K244025 | Argo Knotless GENESYS AnchorMBI · Special | 01/28/2025SE |
| K242187 | BioBrace®OWW · Traditional | 11/27/2024SE |
| K240127 | PlumeSafe X5 Smoke Management SystemFYD · Traditional | 08/05/2024SE |
| K241906 | BioBrace® Reinforced ImplantOWW · Special | 07/29/2024SE |
| K240090 | Argo Knotless GENESYS AnchorMAI · Traditional | 03/05/2024SE |
Questions and answers
When was Beamer Argon Snare Probe cleared by the FDA?
Beamer Argon Snare Probe (K081580) received a 510(k) decision of Substantially Equivalent on June 19, 2008, 14 days after the submission was received.
What is the product code of K081580?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.