Cleared Traditional

K850288 - HEPATIC PARENCHYMAL SUCTION DISSECTOR

K850288 is an FDA 510(k) clearance for HEPATIC PARENCHYMAL SUCTION DISSECTOR, manufactured by Beecher Medical Diagnostic Instrumentation. The device is a Class 1 General & Plastic Surgery device with product code GDI cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K850288 · Beecher Medical Diagnostic Instrumentation · General & Plastic Surgery device
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Mar 1985
Decision
53d
Days
Class 1
Risk

K850288 is an FDA 510(k) clearance for the HEPATIC PARENCHYMAL SUCTION DISSECTOR. Classified as Dissector, Surgical, General & Plastic Surgery (product code GDI), Class I - General Controls.

Submitted by Beecher Medical Diagnostic Instrumentation (Silver Spring, US). The FDA issued a Cleared decision on March 18, 1985 after a review of 53 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.

FDA 510(k) Submission Details - K850288

510(k) Number K850288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1985
Decision Date March 18, 1985
Days to Decision 53 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
62d faster than avg
Panel avg: 115d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

GDI Device Classification - Class 1, General Controls

Product Code GDI Dissector, Surgical, General & Plastic Surgery
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 - GDI Dissector, Surgical, General & Plastic Surgery

Devices cleared under the same product code (GDI) and FDA review panel - the closest regulatory comparables to K850288.
DISPOSABLE EXTERNAL CLAMPS
K896383 · Galenica Enterprises, Inc. · Dec 1989
ROUND-BEEHIVE- DISSECTORS 3/8
K831912 · Ormed Mfg., Inc. · Oct 1983
TYMPANOPLASTY & SKIN DISSECTORS
K822569 · Kelleher Corp. · Oct 1982
FIELD SUCTION DISSECTOR
K803292 · V. Mueller O.V. Baxter Healthcare Corp. · Jan 1981
DISPOSABLE SPECIALITY SPONGES
K791870 · Carwild Corp. · Nov 1979
TEW BYPASS INSTRUMENTS & DISSECTING KIT
K791703 · Edward Weck, Inc. · Oct 1979
K850288 · HEPATIC PARENCHYMAL SUCTION DISSECTOR
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