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)

GELRITE

K-Number: K820610 · 1982-10-27

ApplicantKelco
Decision Date1982-10-27
Product CodeJSK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GELRITE is the device name listed in this FDA 510(k) record. The listed applicant is Kelco. It received FDA 510(k) clearance on 1982-10-27 under 510(k) number K820610. The device is classified under product code JSK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GELRITE?

GELRITE is a medical device that received FDA 510(k) clearance on 1982-10-27. The listed applicant is Kelco. The 510(k) number is K820610.

When did GELRITE receive FDA 510(k) clearance?

GELRITE received FDA 510(k) clearance on 1982-10-27, under 510(k) number K820610.

Who is the listed applicant for GELRITE?

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

What is the FDA product code for GELRITE?

The FDA product code for GELRITE is JSK.

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

Related Devices (Code: JSK)

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.

K881949ATS NAC-PAC SETAlpha-Tec Systems, Inc.K881879ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42Alpha-Tec Systems, Inc.K881566HEMOGLOBIN POWDERAcumedia Manufacturers, Inc.K861997PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTUREHazleton Research Products, Inc.K861791PENICILLIN-STREPTOMYCIN-FUNGIZONEFlow Laboratories, Inc.K861824GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)Flow Laboratories, 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.

↑