Cleared Traditional

OPPORTUNITY I.V. START KIT (K971093) - FDA 510(k) Clearance

K971093 · Opportunity, Inc. · General & Plastic Surgery device
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Sep 1997
Decision
176d
Days
-
Risk

K971093 is an FDA 510(k) clearance for the OPPORTUNITY I.V. START KIT. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Opportunity, Inc. (Highland Park, US). The FDA issued a Cleared decision on September 16, 1997 after a review of 176 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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.

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Submission Details

510(k) Number K971093 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 24, 1997
Decision Date September 16, 1997
Days to Decision 176 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 115d · This submission: 176d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -