ERG-Jet Electrode
by Nicolet Biomedical Instruments
510(k) K813399
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK813399 | Date22 Jan 1982 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.1220
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The ERG-Jet Electrode is a Corneal Electrode, classified under the FDA’s Electrode category (Product Code HLZ) and designated for ophthalmic use. It is designed for electrophysiological testing, specifically electroretinography (ERG), to measure electrical responses from the retina. Constructed as a disposable gold-ring corneal lens electrode, it facilitates precise and non-invasive retinal function assessment. The device adheres to regulatory standards for Class II medical devices under FDA regulation 886.1220.
Supplied in packs of 12, the ERG-Jet Electrode features a 12-millimeter diameter lens and a 100-centimeter connection cable with DIN 1.5mm touch-proof (female) sockets. Sterilized for single-use, it is intended for clinical settings where retinal function evaluation is required. The device holds FDA 510(k) clearance (K813399) under the Traditional pathway, with a Substantially Equivalent determination from the Ophthalmic Advisory Committee. Storage and handling must comply with sterile medical device protocols.
Other devices from Nicolet Biomedical Instruments
Questions
AI-generated answers, 1 Oct 2026
What is the ERG-Jet Electrode used for?
The ERG-Jet Electrode is specifically designed for electroretinography (ERG), a non-invasive electrophysiological test that measures the retina’s electrical responses. This helps clinicians evaluate retinal function, which is critical for diagnosing and monitoring ophthalmic conditions such as retinal dystrophies, glaucoma, or other retinal disorders.
How is the ERG-Jet Electrode supplied, and what are its key features?
The ERG-Jet Electrode comes in sterile, single-use packs containing 12 electrodes. Each electrode features a 12-millimeter diameter gold-ring lens for precise corneal contact and a 100-centimeter connection cable with DIN 1.5mm touch-proof (female) sockets. The design ensures reliable signal transmission while maintaining sterility and ease of use in clinical settings.
Is the ERG-Jet Electrode reusable or intended for single-use?
The ERG-Jet Electrode is explicitly designed for single-use only. It is sterilized before packaging to ensure patient safety and prevent cross-contamination. After use, the electrode should be discarded according to standard sterile medical device protocols.
What storage and handling requirements apply to the ERG-Jet Electrode?
The ERG-Jet Electrode must be stored in a clean, dry environment protected from moisture and extreme temperatures. Since it is sterile and single-use, the packaging should remain intact until use. Follow standard sterile medical device handling procedures to maintain integrity and ensure safety.
What regulatory pathway does the ERG-Jet Electrode follow?
The ERG-Jet Electrode holds FDA 510(k) clearance (K813399) under the Traditional pathway, with a Substantially Equivalent determination from the Ophthalmic Advisory Committee. This classification aligns with its use as a Class II medical device under FDA regulation 886.1220, ensuring it meets established safety and performance standards for corneal electrodes.