Cleared Traditional

K864551 - BIOPSY ADAPTER #H4221BG

K864551 is an FDA 510(k) clearance for BIOPSY ADAPTER #H4221BG, manufactured by General Electric Co.. The device is a Class 1 General & Plastic Surgery device with product code GDF cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K864551 · General Electric Co. · General & Plastic Surgery device
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Dec 1986
Decision
34d
Days
Class 1
Risk

K864551 is an FDA 510(k) clearance for the BIOPSY ADAPTER #H4221BG. Classified as Guide, Needle, Surgical (product code GDF), Class I - General Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on December 23, 1986 after a review of 34 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 General Electric Co. devices

FDA 510(k) Submission Details - K864551

510(k) Number K864551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1986
Decision Date December 23, 1986
Days to Decision 34 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 115d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

GDF Device Classification - Class 1, General Controls

Product Code GDF Guide, Needle, Surgical
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 - GDF Guide, Needle, Surgical

All 15
Devices cleared under the same product code (GDF) and FDA review panel - the closest regulatory comparables to K864551.
SURGICAL NEEDLE GUIDE
K890228 · Kinetic Medical Products · Jan 1989
SURGICAL NEEDLE HOLDERS
K890229 · Kinetic Medical Products · Jan 1989
WILLIAMS ACS MARKER NEEDLE
K882036 · Buckman Co., Inc. · Jul 1988
PERCU GUIDE I (LOOP TYPE)
K863090 · E-Z-Em, Inc. · Aug 1986
BIOPSY ADAPTER H4222W
K861050 · General Electric Co. · Apr 1986
MENISCAL SUTURE GUN
K832978 · Instrument Makar, Inc. · Dec 1983