Cleared Traditional

K780784 - ASPIRATION NEEDLE

K780784 is an FDA 510(k) clearance for ASPIRATION NEEDLE, manufactured by Ferris Mfg. Corp.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K780784

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
Combination Product No
PCCP Authorized No
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.

KKX Device Classification - Class 2, Special Controls

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 271
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