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)

OMNI PREP GEL

K-Number: K933797 · 1994-05-17

ApplicantCadwell Laboratories, Inc.
Decision Date1994-05-17
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OMNI PREP GEL is the device name listed in this FDA 510(k) record. The listed applicant is Cadwell Laboratories, Inc.. It received FDA 510(k) clearance on 1994-05-17 under 510(k) number K933797. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI PREP GEL?

OMNI PREP GEL is a medical device that received FDA 510(k) clearance on 1994-05-17. The listed applicant is Cadwell Laboratories, Inc.. The 510(k) number is K933797.

When did OMNI PREP GEL receive FDA 510(k) clearance?

OMNI PREP GEL received FDA 510(k) clearance on 1994-05-17, under 510(k) number K933797.

Who is the listed applicant for OMNI PREP GEL?

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

What is the FDA product code for OMNI PREP GEL?

The FDA product code for OMNI PREP GEL is GYB.

Other records listing Cadwell Laboratories, 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.

K061706CADWELL EASYNET OXIMETER MODULEK061705CADWELL EASYNET NASAL PRESSURE MODULEK042350TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATORK040986CADWELL LIMB MOVEMENT MODULEK040932EASYNET BODY POSITION MODULEK971214KILOWIN

View all 46 devices →

Related Devices (Code: GYB)

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.

K243749Jmoon Conductive GelShenzhen Ulike Smart Electronics Co., Ltd.K220735Avologi Gel Primer (Model: Av25)Premier North America, Inc.K222770Conductive GelTop-Rank Health Care Co., Ltd.K221724Conductive GelTone-A-Matic International, Inc.K212325EEG-acpSomnomedics GmbHK212326AC Cream - Conductive pasteSpes Medica Srl

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.

↑