Cleared Traditional

K930158 - BONE MARROW BIOPSY PROCEDURE TRAY

K930158 is an FDA 510(k) clearance for BONE MARROW BIOPSY PROCEDURE TRAY, manufactured by Symbiosis Corp.. The device is a Class 1 General & Plastic Surgery device with product code GAA cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K930158 · Symbiosis Corp. · General & Plastic Surgery device
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Jul 1993
Decision
170d
Days
Class 1
Risk

K930158 is an FDA 510(k) clearance for the BONE MARROW BIOPSY PROCEDURE TRAY. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Symbiosis Corp. (Miami, US). The FDA issued a Cleared decision on July 2, 1993 after a review of 170 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 Symbiosis Corp. devices

FDA 510(k) Submission Details - K930158

510(k) Number K930158 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received January 13, 1993
Decision Date July 02, 1993
Days to Decision 170 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 115d · This submission: 170d
Pathway characteristics
Predicate-based equivalence.

GAA Device Classification - Class 1, General Controls

Product Code GAA Needle, Aspiration And Injection, Disposable
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 - GAA Needle, Aspiration And Injection, Disposable

All 41
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K930158.
MONOJECT BONE MARROW BIOPSY TRAYS
K945109 · Sherwood Medical Co. · Nov 1994
MANAN GENERAL PURPOSE INTRODUCER NEEDLE
K940024 · Manan Medical Products, Inc. · Feb 1994
MANAN BONE MARROW HARVEST NEEDLES
K940025 · Manan Medical Products, Inc. · Feb 1994
GILLAM-TUKEL BONE MARROW BIOPSY NEEDLE
K924501 · Symbiosis Corp. · Apr 1993
SYMBIOSIS BONE MARROW BIOPSY NEEDLE
K925416 · Symbiosis Corp. · Feb 1993
TURKEL THORACENTESIS SYSTEM
K922614 · Symbiosis Corp. · Jul 1992