Cleared Traditional

FiXcision (K182664) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K182664 · Agency For Medical Innovations GmbH · Gastroenterology & Urology device
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Dec 2018
Decision
73d
Days
Class 1
Risk

K182664 is an FDA 510(k) clearance for the FiXcision. Classified as Surgical Instruments, G-u, Manual (and Accessories) (product code KOA), Class I - General Controls.

Submitted by Agency For Medical Innovations GmbH (Feldkirch, AT). The FDA issued a Cleared decision on December 7, 2018 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4730 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Agency For Medical Innovations GmbH devices

Submission Details

510(k) Number K182664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2018
Decision Date December 07, 2018
Days to Decision 73 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
57d faster than avg
Panel avg: 130d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KOA Surgical Instruments, G-u, Manual (and Accessories)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4730
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Acknowledge Regulatory Strategies, LLC
Allison C. Komiyama

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.