Cleared Traditional

K771732 - THORNTON ANTERIOR CHAMBER IRRIGATOR

K771732 is an FDA 510(k) clearance for THORNTON ANTERIOR CHAMBER IRRIGATOR, manufactured by Concept, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBQ cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K771732 · Concept, Inc. · General & Plastic Surgery device
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Sep 1977
Decision
13d
Days
Class 1
Risk

K771732 is an FDA 510(k) clearance for the THORNTON ANTERIOR CHAMBER IRRIGATOR. Classified as Catheter, Continuous Irrigation (product code GBQ), Class I - General Controls.

Submitted by Concept, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 28, 1977 after a review of 13 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - 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: 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 Concept, Inc. devices

FDA 510(k) Submission Details - K771732

510(k) Number K771732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1977
Decision Date September 28, 1977
Days to Decision 13 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
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

GBQ Device Classification - Class 1, General Controls

Product Code GBQ Catheter, Continuous Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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.