Cleared Traditional

K780784 - ASPIRATION NEEDLE

K780784 is the FDA 510(k) clearance for ASPIRATION NEEDLE by Ferris Mfg. Corp.. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K780784 · Ferris Mfg. Corp. · General Hospital
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Aug 1978
Decision
94d
Days
Class 2
Risk

K780784 is an FDA 510(k) clearance for the ASPIRATION NEEDLE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Ferris Mfg. Corp. (Mchenry, US). The FDA issued a Cleared decision on August 14, 1978 after a review of 94 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Ferris Mfg. Corp. devices

Submission Details

510(k) Number K780784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1978
Decision Date August 14, 1978
Days to Decision 94 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 129d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - KKX Drape, Surgical

All 160
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K780784.
STOCKINETTE
K781944 · Kimberly-Clark Corp. · Dec 1978
U-DRAPE, BOUNDARY
K781172 · Procter & Gamble Mfg. Co. · Aug 1978
MAGNETIC DRAPE - INSTRUMENT HOLDER
K780865 · Devon Industries, Inc. · Aug 1978
BARRIER PEDIATRIC/INCISE DRAPE 450
K780839 · Surgikos, Inc. · Aug 1978
BARRIER LAPAROTOMY SHEET 450
K780840 · Surgikos, Inc. · Aug 1978
BARRIER MEDIUM SHEET 450
K780841 · Surgikos, Inc. · Aug 1978