Cleared Traditional

K926508 - INTRASITE GEL

K926508 is the FDA 510(k) clearance for INTRASITE GEL by Smith & Nephew United, Inc.. It is a Class 1 General & Plastic Surgery device (product code NAE) cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K926508 · Smith & Nephew United, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
195d
Days
Class 1
Risk

K926508 is an FDA 510(k) clearance for the INTRASITE GEL. Classified as Dressing, Wound, Hydrogel Without Drug And/or Biologic (product code NAE), Class I - General Controls.

Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on July 13, 1993 after a review of 195 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4022 - the FDA general and plastic surgery device framework. 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 K926508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1992
Decision Date July 13, 1993
Days to Decision 195 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 115d · This submission: 195d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NAE Dressing, Wound, Hydrogel Without Drug And/or Biologic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4022
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - NAE Dressing, Wound, Hydrogel Without Drug And/or Biologic

All 10
Devices cleared under the same product code (NAE) and FDA review panel - the closest regulatory comparables to K926508.
ALLEVYN ISLAND WOUND DRESSING
K935705 · Smith & Nephew United, Inc. · Feb 1994
NU-GEL ISLAND WOUND DRESSING
K932336 · Johnson & Johnson Medical, Inc. · Feb 1994
DUODERM HYDROCOLLOID GEL
K931618 · Convatec, A Division of E.R. Squibb & Sons · Dec 1993
PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH
K915357 · Medtronic Vascular · May 1992
PROMEON HYDROGEL DRESSING #45 STERILE W/ MESH
K915359 · Medtronic Vascular · May 1992
DEROYAL HYDROGEL DRESSING
K915182 · Deroyal Industries, Inc. · Apr 1992