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

Submission Details

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.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 222
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K891870.
DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK
K904852 · Convatec, A Division of E.R. Squibb & Sons · Jan 1991
WOUND TREATMENT KIT
K901109 · Orion Life Systems, Inc. · Jun 1990
SILASTIC SOFT SHEETING
K894226 · Dow Corning Wright · Jan 1990
CUTINOVA(R) PLUS ON VASCULAR STASIS ULCERS
K885279 · Beiersdorf, Inc. · Jun 1989
TEGASORB(TM) ULCER DRESSING, #90-XXX
K891288 · 3M Company · Jun 1989
ACTIDERM*-OPAQUE
K892232 · Convatec, A Division of E.R. Squibb & Sons · May 1989