gi-4000 Electrosurgical Generator
FDA 510(k) K172805 · United States Endoscopy Group, Inc.
510(k) numberK172805
Submission
- Device name
- gi-4000 Electrosurgical Generator
- Applicant
- United States Endoscopy Group, Inc.
Mentor, OH, US - Received
- September 18, 2017
- Decision date
- October 23, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K192265 | gi-4000 Electrosurgical GeneratorGEI · Traditional | 05/21/2020SE |
| K200745 | Lariat, Hot/Cold SnareFDI · Special | 04/21/2020SE |
| K192059 | Bio Guard Air/Water & Suction ValvesODC · Special | 09/17/2019SE |
| K191559 | AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILMFEQ · Special | 08/01/2019SE |
| K182909 | Roth Net Retriever Product LineFDI · Special | 11/21/2018SE |
| K182258 | AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - FujifilmFEQ · Special | 09/21/2018SE |
| K173650 | AquaShield System CO2- FujifilmFEQ · Special | 01/05/2018SE |
| K163495 | AdvanCE capsule endoscope delivery deviceNEZ · Traditional | 03/10/2017SE |
| K163492 | Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon…FDF · Special | 01/06/2017SE |
| K153362 | AquaShield system CO2, AquaShield system-PENTAXFEQ · Special | 12/16/2015SE |
Questions and answers
When was gi-4000 Electrosurgical Generator cleared by the FDA?
gi-4000 Electrosurgical Generator (K172805) received a 510(k) decision of Substantially Equivalent on October 23, 2017, 35 days after the submission was received.
What is the product code of K172805?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.