Cleared Traditional

K892069 - EXTENDED COVERS, STERILE (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K892069 · Amedic USA · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1989
Decision
130d
Days
Class 1
Risk

K892069 is an FDA 510(k) clearance for the EXTENDED COVERS, STERILE. Classified as Cover, Biopsy Forceps (product code FFF), Class I - General Controls.

Submitted by Amedic USA (Sweden, SE). The FDA issued a Cleared decision on August 8, 1989 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - 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 Amedic USA devices

Submission Details

510(k) Number K892069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1989
Decision Date August 08, 1989
Days to Decision 130 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 130d · This submission: 130d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FFF Cover, Biopsy Forceps
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1075
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.