Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

STERILE WOUND HYDROGEL DRESSING

K-Number: K941339 · 1994-06-10

ApplicantRenaissance Pharmaceutical, Inc.
Decision Date1994-06-10
Product CodeMGQ
DecisionSubstantially Equivalent

Device Summary

STERILE WOUND HYDROGEL DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Renaissance Pharmaceutical, Inc.. It received FDA 510(k) clearance on 1994-06-10 under 510(k) number K941339. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE WOUND HYDROGEL DRESSING?

STERILE WOUND HYDROGEL DRESSING is a medical device that received FDA 510(k) clearance on 1994-06-10. The listed applicant is Renaissance Pharmaceutical, Inc.. The 510(k) number is K941339.

When did STERILE WOUND HYDROGEL DRESSING receive FDA 510(k) clearance?

STERILE WOUND HYDROGEL DRESSING received FDA 510(k) clearance on 1994-06-10, under 510(k) number K941339.

Who is the listed applicant for STERILE WOUND HYDROGEL DRESSING?

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

What is the FDA product code for STERILE WOUND HYDROGEL DRESSING?

The FDA product code for STERILE WOUND HYDROGEL DRESSING 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Renaissance Pharmaceutical, Inc. as applicant

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.

K961316WOUND HYDROGEL AND/OR STERILE WOUND HYDROGELK961766WOUND HYDROGEL & STERILE WOUND HYDROGELK954384WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL

Related Devices (Code: MGQ)

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.

K171879HylaGuard Moisturizing CreamFounders Science Group, LLCK083024HYLATOPIC EMOLLIENT FOAMCollegium Pharmaceutical IncorporatedK041342IMPRUV A.I. CREAM WOUND AND SKIN EMULSIONStiefel Laboratories, Inc.K041268SILVERSITE OR CALGITROLAdriK040019SILVERSEALNoble Fiber TechnologiesK040517TENDERWET 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.

↑