Cleared Traditional

K833720 - TRANSTHORACIC/TRANSABDOMINAL-TRAY

K833720 is an FDA 510(k) clearance for TRANSTHORACIC/TRANSABDOMINAL-TRAY, manufactured by Applied Medical Devices, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDM cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K833720 · Applied Medical Devices, Inc. · General & Plastic Surgery device
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May 1984
Decision
219d
Days
Class 1
Risk

K833720 is an FDA 510(k) clearance for the TRANSTHORACIC/TRANSABDOMINAL-TRAY. Classified as Needle, Aspiration And Injection, Reusable (product code GDM), Class I - General Controls.

Submitted by Applied Medical Devices, Inc. (Walker, US). The FDA issued a Cleared decision on May 30, 1984 after a review of 219 days - an extended review 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: 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 Applied Medical Devices, Inc. devices

FDA 510(k) Submission Details - K833720

510(k) Number K833720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1983
Decision Date May 30, 1984
Days to Decision 219 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 115d · This submission: 219d
Pathway characteristics
Predicate-based equivalence.

GDM Device Classification - Class 1, General Controls

Product Code GDM Needle, Aspiration And Injection, Reusable
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.

Regulatory Peers - GDM Needle, Aspiration And Injection, Reusable

All 17
Devices cleared under the same product code (GDM) and FDA review panel - the closest regulatory comparables to K833720.
SPINAL NEEDLE
K880812 · T. Korossurgical Instruments Corp. · Mar 1988
WHOLEY (TM) BIOPSY DEVICE
K874928 · Medrad, Inc. · Dec 1987
CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE
K862481 · CIVCO Medical Instruments Co., Inc. · Jul 1986
ISLAM BONE MARROW BIOPSY NEEDLE
K820339 · Downs Surgical , Ltd. · Feb 1982