Cleared Traditional

K771049 - ENDOSCOPIC TRAY

K771049 is an FDA 510(k) clearance for ENDOSCOPIC TRAY, manufactured by American Hospital Supply Corp.. The device is a Class 1 General & Plastic Surgery device with product code MMO cleared through the Traditional 510(k) pathway after a 94-day FDA review.

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

FDA 510(k) Submission Details - K771049

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 115d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

MMO Device Classification - Class 1, General Controls

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.