Cleared Traditional

K971061 - OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY

K971061 is an FDA 510(k) clearance for OPPORTUNITY INC. BONE MARROW BIOPSY AND..., manufactured by Opportunity, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LRO cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K971061 · Opportunity, Inc. · General & Plastic Surgery device
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Jun 1997
Decision
79d
Days
Class 2
Risk

K971061 is an FDA 510(k) clearance for the OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Opportunity, Inc. (Highland Park, US). The FDA issued a Cleared decision on June 11, 1997 after a review of 79 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4370 - 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 Opportunity, Inc. devices

FDA 510(k) Submission Details - K971061

510(k) Number K971061 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 24, 1997
Decision Date June 11, 1997
Days to Decision 79 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
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRO Device Classification - Class 2, Special Controls

Product Code LRO General Surgery Tray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - LRO General Surgery Tray

All 59
Devices cleared under the same product code (LRO) and FDA review panel - the closest regulatory comparables to K971061.
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OPPORTUNITY INC. GENERAL PURPOSE TRAY
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PRESBYTERIAN LINEN SERVICES SURGICAL PACKS
K970286 · Medline Industries, Inc. · Mar 1997