ClearHemograsper— 510(k) K242857
Substantially EquivalentFinemedix Co., Ltd.
FDA 510(k) clearance K242857 for ClearHemograsper, Substantially Equivalent on 2025-05-21. Applicant: Finemedix Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Finemedix Co., Ltd.
- Product code
- Code KGE
- Device class
- Class 2
- Regulation
- 21 CFR 876.4300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Daegu, KR
Recent devices under product code KGE
view all- K251807 — Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR
- K250187 — Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)
- K231721 — Disposable Hot Biopsy Forceps
- K220053 — Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI
- K210406 — Bipolar Coagulation Foreceps
More clearances from Finemedix Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.