Cleared Traditional

K780153 - HOUSE SUCTION IRRIGATOR

K780153 is an FDA 510(k) clearance for HOUSE SUCTION IRRIGATOR, manufactured by Edward Weck, Inc.. The device is a Class 1 General & Plastic Surgery device with product code JYC cleared through the Traditional 510(k) pathway after a 3-day FDA review.

K780153 · Edward Weck, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1978
Decision
3d
Days
Class 1
Risk

K780153 is an FDA 510(k) clearance for the HOUSE SUCTION IRRIGATOR. Classified as Cannula, Ear (product code JYC), Class I - General Controls.

Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 2, 1978 after a review of 3 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Edward Weck, Inc. devices

FDA 510(k) Submission Details - K780153

510(k) Number K780153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1978
Decision Date February 02, 1978
Days to Decision 3 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
112d faster than avg
Panel avg: 115d · This submission: 3d
Pathway characteristics
Predicate-based equivalence.

JYC Device Classification - Class 1, General Controls

Product Code JYC Cannula, Ear
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.