Cleared Traditional

K990440 - GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE

K990440 · Gentell · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
182d
Days
-
Risk

K990440 is an FDA 510(k) clearance for the GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Gentell (Washington, US). The FDA issued a Cleared decision on August 12, 1999 after a review of 182 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 Gentell devices

FDA 510(k) Submission Details - K990440

510(k) Number K990440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1999
Decision Date August 12, 1999
Days to Decision 182 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
67d slower than avg
Panel avg: 115d · This submission: 182d
Pathway characteristics
Predicate-based equivalence.

MGQ Device Classification - Class 0,

Product Code MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class -

Regulatory Peers - MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

All 65
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K990440.
BURNFREE PAIN RELIEVING GEL, MODEL 4B
K990178 · Nortrade Medical, Inc. · Aug 1999
BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD
K990179 · Nortrade Medical, Inc. · Aug 1999
BURNFREE (4X4, 8X8, 16X24) STERILE BURN & WOUND DRESSING
K990180 · Nortrade Medical, Inc. · Aug 1999
MODIFICATION TO WOUN'DRES
K991202 · Coloplast Corp. · Jun 1999
DUODERM HYDROACTIVE GEL WOUND DRESSING
K990368 · Convatec, A Bristol-Myers Squibb Co. · Mar 1999
HYPERGEL 20% HYPERTONIC SALINE GEL
K984370 · Molnlycke Health Care, Inc. · Mar 1999