ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)
FDA 510(k) K233113 · Starmed Co., Ltd.
510(k) numberK233113
Submission
- Device name
- ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)
- Applicant
- Starmed Co., Ltd.
Goyang-Si, KR - Received
- September 27, 2023
- Decision date
- October 25, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KNS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262460 | Rezum SystemKNS · Traditional | Boston Scientific | 09/03/2026SE |
| K260962 | SphincterotomeKNS · Traditional | Taewoong Medical Co., Ltd. | 05/21/2026SE |
| K252388 | Vanquish Water Vapor Ablation DeviceKNS · Traditional | Francis Medical, Inc. | 11/26/2025SE |
| K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)KNS · Traditional | Olympus Medical Systems Corporation | 11/25/2025SE |
| K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use…KNS · Traditional | Olympus Medical Systems Corp. | 10/17/2025SE |
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife…KNS · Traditional | Olympus Medical Systems Corporation | 10/10/2025SE |
| K251104 | SureTome SW Sphincterotome with DomeTipKNS · Traditional | Wilson-Cook Medical | 09/29/2025SE |
| K251226 | Aqua Medical RF Vapor Ablation SystemKNS · Traditional | Aqua Medical, Inc. | 08/08/2025SE |
| K250584 | Rezum SystemKNS · Traditional | Boston Scientific Corporation | 06/11/2025SE |
| K242774 | SpydrBlade Flex Instrument (PRD-RG1-001)KNS · Traditional | Creo Medical, Ltd. | 06/06/2025SE |
More from Creo Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K252833 | VIVA combo RF SystemGEI · Traditional | 05/26/2026SE |
| K251566 | TS-RF Generator (STS10)GEI · Traditional | 11/17/2025SE |
| K234140 | VIVA combo RF System (VIVA combo RF System)GEI · Special | 01/30/2024SE |
| K222997 | VVR Generator systemGEI · Traditional | 10/25/2023SE |
| K203795 | Star RF Electrode, VIVA RF ElectrodeGEI · Traditional | 04/01/2021SE |
| K181758 | ELRA ElectrodeKNS · Traditional | 04/11/2019SE |
| K183538 | VIVA combo RF SystemGEI · Special | 01/17/2019SE |
| K181249 | EUSRA RF ElectrodeGEI · Traditional | 09/04/2018SE |
| K172012 | star RF Electrode, VIVA RF ElectrodeGEI · Traditional | 03/14/2018SE |
| K163450 | VIVA combo RF SystemGEI · Traditional | 03/08/2017SE |
Questions and answers
When was ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) cleared by the FDA?
ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) (K233113) received a 510(k) decision of Substantially Equivalent on October 25, 2023, 28 days after the submission was received.
What is the product code of K233113?
The FDA product code is KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.4300.