Cleared Traditional

BIOACCESS MARROW HARVEST SYSTEM (K971114) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K971114 · Bioaccess, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
69d
Days
Class 1
Risk

K971114 is an FDA 510(k) clearance for the BIOACCESS MARROW HARVEST SYSTEM. Classified as Needle, Aspiration And Injection, Reusable (product code GDM), Class I - General Controls.

Submitted by Bioaccess, Inc. (Silver Spring, US). The FDA issued a Cleared decision on June 3, 1997 after a review of 69 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 Bioaccess, Inc. devices

Submission Details

510(k) Number K971114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1997
Decision Date June 03, 1997
Days to Decision 69 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 115d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.