Cleared Traditional

K971093 - OPPORTUNITY I.V. START KIT

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.

View all Opportunity, Inc. devices

FDA 510(k) Submission Details - K971093

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 115d · This submission: 176d
Pathway characteristics
Predicate-based equivalence.

MGP Device Classification - Class 0,

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

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

All 35
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K971093.
TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING
K973312 · Innovative Technologies , Ltd. · Oct 1997
HYDRASORB STERILE DRESSING
K973260 · Avitar, Inc. · Oct 1997
LYOCELL WOUND DRESSING/SURGICAL SPONGE
K972458 · Courtaulds Fibers, Inc. · Sep 1997
ALGOPLAQUE HYDROCOLLOID DRESSING
K970518 · Laboratoires Urgo S.A. · Mar 1997
NASP TRANSPARENT DRESSING
K963753 · North American Sterilization & Packaging Co. · Nov 1996
SPYROFLEX PIGMENTED WOUND DRESSING
K963623 · Polymedica Industries, Inc. · Oct 1996