Cleared Traditional

K933364 - PROMED BIOPSY NEEDLE

K933364 is an FDA 510(k) clearance for PROMED BIOPSY NEEDLE, manufactured by Vlv Associates, Inc.. The device is a Class 1 General & Plastic Surgery device with product code DWO cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K933364 · Vlv Associates, Inc. · General & Plastic Surgery device
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Feb 1994
Decision
221d
Days
Class 1
Risk

K933364 is an FDA 510(k) clearance for the PROMED BIOPSY NEEDLE. Classified as Needle, Biopsy, Cardiovascular (product code DWO), Class I - General Controls.

Submitted by Vlv Associates, Inc. (East Hanover, US). The FDA issued a Cleared decision on February 15, 1994 after a review of 221 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 Vlv Associates, Inc. devices

FDA 510(k) Submission Details - K933364

510(k) Number K933364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1993
Decision Date February 15, 1994
Days to Decision 221 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 115d · This submission: 221d
Pathway characteristics
Predicate-based equivalence.

DWO Device Classification - Class 1, General Controls

Product Code DWO Needle, Biopsy, Cardiovascular
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 - DWO Needle, Biopsy, Cardiovascular

Devices cleared under the same product code (DWO) and FDA review panel - the closest regulatory comparables to K933364.
ULTRA-CORE BIOPSY NEEDLES
K921418 · Medical Device Technologies, Inc. · Jun 1992
MANAN BONE MARROW BIOPSY NEEDLE
K890925 · Manan Medical Products, Inc. · Apr 1989
MEDSURG GREENE NEEDLE
K885145 · Medsurg Industries, Inc. · Mar 1989
ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE
K874585 · Angiomed U.S., Inc. · Dec 1987
ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES
K853312 · Argon Medical Corp. · Sep 1985
RNG SERIES ULTRASOUND NEEDLE/CATH. GDS
K820269 · CIVCO Medical Instruments Co., Inc. · Mar 1982