Cleared Traditional

K984370 - HYPERGEL 20% HYPERTONIC SALINE GEL

K984370 · Molnlycke Health Care, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
84d
Days
-
Risk

K984370 is an FDA 510(k) clearance for the HYPERGEL 20% HYPERTONIC SALINE GEL. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Molnlycke Health Care, Inc. (Eddystone, US). The FDA issued a Cleared decision on March 1, 1999 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Molnlycke Health Care, Inc. devices

FDA 510(k) Submission Details - K984370

510(k) Number K984370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1998
Decision Date March 01, 1999
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
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 98
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K984370.
GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE
K990440 · Gentell · 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
NORMLGEL 0.9% ISOTONIC SALINE GEL
K984368 · Molnlycke Health Care, Inc. · Feb 1999
MODIFICATION OF BIONECT HYDROGEL GAUZE PADS
K984262 · Fidia Pharmaceutical Corp. · Feb 1999
MODIFICATION OF BIONECT CLEAR HYDROGEL
K984264 · Fidia Pharmaceutical Corp. · Feb 1999