Cleared Traditional

K891870 - INTRASITE* GEL (3) YEAR SHELF LIFE

K891870 · Smith & Nephew United, Inc. · General & Plastic Surgery device
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Aug 1989
Decision
152d
Days
-
Risk

K891870 is an FDA 510(k) clearance for the INTRASITE* GEL (3) YEAR SHELF LIFE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on August 9, 1989 after a review of 152 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 Smith & Nephew United, Inc. devices

FDA 510(k) Submission Details - K891870

510(k) Number K891870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1989
Decision Date August 09, 1989
Days to Decision 152 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
37d slower than avg
Panel avg: 115d · This submission: 152d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 501
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K892364 · Calgon Vestal Div. · Jun 1989
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K885279 · Beiersdorf, Inc. · Jun 1989