FDA 510(k)

HYPERGEL 20% HYPERTONIC SALINE GEL

K-Number: K984370 · 1999-03-01

Decision Date1999-03-01

Product CodeMGQ

DecisionSubstantially Equivalent

Device Summary

HYPERGEL 20% HYPERTONIC SALINE GEL is the device name listed in this FDA 510(k) record. The listed applicant is Molnlycke Health Care, Inc.. It received FDA 510(k) clearance on 1999-03-01 under 510(k) number K984370. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPERGEL 20% HYPERTONIC SALINE GEL?

HYPERGEL 20% HYPERTONIC SALINE GEL is a medical device that received FDA 510(k) clearance on 1999-03-01. The listed applicant is Molnlycke Health Care, Inc.. The 510(k) number is K984370.

When did HYPERGEL 20% HYPERTONIC SALINE GEL receive FDA 510(k) clearance?

HYPERGEL 20% HYPERTONIC SALINE GEL received FDA 510(k) clearance on 1999-03-01, under 510(k) number K984370.

Who is the listed applicant for HYPERGEL 20% HYPERTONIC SALINE GEL?

The FDA 510(k) record lists Molnlycke Health Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYPERGEL 20% HYPERTONIC SALINE GEL?

The FDA product code for HYPERGEL 20% HYPERTONIC SALINE GEL is MGQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Molnlycke Health Care, Inc. as applicant

K062138POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE K051625BARRIER SURGICAL DRAPES K000902KLINIDRAPE REINFORCED SURGICAL GOWNS K000901KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION K000906KLINIDRAPE SURGICAL DRAPES K984371MEPITEL NON ADHERENT SILICONE DRESSING

View all 10 devices →

Related Devices (Code: MGQ)

K171879HylaGuard Moisturizing CreamFounders Science Group, LLC K083024HYLATOPIC EMOLLIENT FOAMCollegium Pharmaceutical Incorporated K041342IMPRUV A.I. CREAM WOUND AND SKIN EMULSIONStiefel Laboratories, Inc.K041268SILVERSITE OR CALGITROLAdri K040019SILVERSEALNoble Fiber Technologies K040517TENDERWET ACTIVEMedline Industries, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.