FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

E-Z Lubricating Jelly is a medical device intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices.

E-Z Lubricating Jelly (sterile) is a medical device intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when a sterile field Is required.

Device Description

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AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA for a medical device called "E-Z Lubricating Jelly". It primarily focuses on regulatory approval based on "substantial equivalence" to a predicate device.

Therefore, this document does not contain information on acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods.

The FDA letter confirms that the device is substantially equivalent for its intended use, which is "to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices," and "when a sterile field is required" for the sterile version.

The information requested in the prompt (acceptance criteria, study details, sample sizes, expert involvement, etc.) would typically be found in a separate study report or the technical documentation submitted by Chester Labs, Inc. to the FDA, not in the FDA's clearance letter itself.

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K Number

K001705

Device Name

STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF

Manufacturer

CHESTER LABS, INC.

Date Cleared

2000-06-29

(24 days)

Product Code