Cleared Traditional

K972185 - 20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE

K972185 · Steripak, Ltd. · General & Plastic Surgery device
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Mar 1998
Decision
268d
Days
-
Risk

K972185 is an FDA 510(k) clearance for the 20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Steripak, Ltd. (Runcorn, Cheshire, GB). The FDA issued a Cleared decision on March 5, 1998 after a review of 268 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 Steripak, Ltd. devices

FDA 510(k) Submission Details - K972185

510(k) Number K972185 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 10, 1997
Decision Date March 05, 1998
Days to Decision 268 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
153d slower than avg
Panel avg: 115d · This submission: 268d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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