Cleared Traditional

K242857 - ClearHemograsper (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242857 · Finemedix Co., Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
May 2025
Decision
243d
Days
Class 2
Risk

K242857 is an FDA 510(k) clearance for the ClearHemograsper. Classified as Forceps, Biopsy, Electric (product code KGE), Class II - Special Controls.

Submitted by Finemedix Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on May 21, 2025 after a review of 243 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Finemedix Co., Ltd. devices

Submission Details

510(k) Number K242857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2024
Decision Date May 21, 2025
Days to Decision 243 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 130d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KGE Forceps, Biopsy, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

KMC, Inc.
Woo Seok Jeong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KGE Forceps, Biopsy, Electric

All 45
Devices cleared under the same product code (KGE) and FDA review panel - the closest regulatory comparables to K242857.
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