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)

MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL

K-Number: K883619 · 1989-09-01

ApplicantMinnetonka, Inc.
Decision Date1989-09-01
Product CodeSEK
DecisionSubstantially Equivalent for Some Indications

Device Summary

MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL is the device name listed in this FDA 510(k) record. The listed applicant is Minnetonka, Inc.. It received FDA 510(k) clearance on 1989-09-01 under 510(k) number K883619. The device is classified under product code SEK. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL?

MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL is a medical device that received FDA 510(k) clearance on 1989-09-01. The listed applicant is Minnetonka, Inc.. The 510(k) number is K883619.

When did MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL receive FDA 510(k) clearance?

MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL received FDA 510(k) clearance on 1989-09-01, under 510(k) number K883619.

Who is the listed applicant for MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL?

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

What is the FDA product code for MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL?

The FDA product code for MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL is SEK.

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 Minnetonka, 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.

K883566MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GELK860843CHECK-UP PLAQUE FIGHTING GUMK831488DAVRON PROF. SCRUB BRUSH-DRY/STERILE

Related Devices (Code: SEK)

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.

K883566MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GELMinnetonka, 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.

↑