Core-Snare

FDA 510(k) K220846 · Incore Co., Ltd.

Substantially Equivalent

510(k) numberK220846

Submission

Device name
Core-Snare
Applicant
Incore Co., Ltd.
Daegu, KR
Received
March 23, 2022
Decision date
November 21, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FDI – Snare, Flexible
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4300
Specialty
Gastroenterology, Urology

Other 510(k)s with product code FDI

510(k)DeviceApplicantDecision
K251692Advanced Tissue Resection DeviceFDI · Traditional Micro-Tech (Nanjing) Co., Ltd.02/21/2026SE
K221713Polypectomy SnareFDI · Traditional Hangzhou AGS MedTech Co., Ltd.03/03/2023SE
K220089Disposable Polyp SnareFDI · Traditional Jiangsu Vedkang Medical Science and Technology…09/22/2022SE
K220790Disposable Polypectomy Snare, Disposable Polypectomy Hybrid SnareFDI · Traditional Yangzhou Fartley Medical Instrument Technology…06/27/2022SE
K213222Disposable Polypectomy SnareFDI · Traditional Beijing Zksk Technology Co., Ltd.06/06/2022SE
K212860SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P…FDI · Special STERIS Corporation10/07/2021SE
K202478Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy SnaresFDI · Special Boston Scientific Corporation10/08/2020SE
K200745Lariat, Hot/Cold SnareFDI · Special United States Endoscopy Group, Inc.04/21/2020SE
K190512SmartBand EMR Kit, SmartBand EMR Pack, SmartSnareFDI · Traditional Intelligent Endoscopy11/22/2019SE
K191048AcuSnare Polypectomy Snare - DuckbillFDI · Special Wilson-Cook Medical, Inc.07/18/2019SE

More from Wilson-Cook Medical, Inc.

510(k)DeviceDecision
K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)QSY · Traditional 04/19/2024SE
K221054Core-InjectorFBK · Traditional 12/21/2022SE
K220081Core-SportOTJ · Traditional 09/28/2022SE
K213338Core-ClipPKL · Traditional 06/23/2022SE
K211148CORE-TrocarGCJ · Traditional 06/21/2022SE

Questions and answers

When was Core-Snare cleared by the FDA?

Core-Snare (K220846) received a 510(k) decision of Substantially Equivalent on November 21, 2022, 243 days after the submission was received.

What is the product code of K220846?

The FDA product code is FDI – Snare, Flexible, a Class II (moderate risk) device regulated under 21 CFR 876.4300.