Cleared Traditional

K771049 - ENDOSCOPIC TRAY (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K771049 · American Hospital Supply Corp. · General & Plastic Surgery device
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Sep 1977
Decision
94d
Days
Class 1
Risk

K771049 is an FDA 510(k) clearance for the ENDOSCOPIC TRAY. Classified as Tray, Surgical, Ent (product code MMO), Class I - General Controls.

Submitted by American Hospital Supply Corp. (Mcgaw Park, US). The FDA issued a Cleared decision on September 12, 1977 after a review of 94 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 874.4420 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all American Hospital Supply Corp. devices

Submission Details

510(k) Number K771049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1977
Decision Date September 12, 1977
Days to Decision 94 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 114d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MMO Tray, Surgical, Ent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
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.