Cleared Traditional

K913815 - AUTOMATED BIOPSY DEVICE, MODIFICATION

K913815 is an FDA 510(k) clearance for AUTOMATED BIOPSY DEVICE, manufactured by Hart Enterprises, Inc.. The device is a Class 1 General & Plastic Surgery device with product code DWO cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K913815 · Hart Enterprises, Inc. · General & Plastic Surgery device
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Oct 1991
Decision
65d
Days
Class 1
Risk

K913815 is an FDA 510(k) clearance for the AUTOMATED BIOPSY DEVICE, MODIFICATION. Classified as Needle, Biopsy, Cardiovascular (product code DWO), Class I - General Controls.

Submitted by Hart Enterprises, Inc. (Wyoming, US). The FDA issued a Cleared decision on October 30, 1991 after a review of 65 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 Hart Enterprises, Inc. devices

FDA 510(k) Submission Details - K913815

510(k) Number K913815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1991
Decision Date October 30, 1991
Days to Decision 65 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
50d faster than avg
Panel avg: 115d · This submission: 65d
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 K913815.
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