FDA PRODUCT CODE · CLASS II
JOS — Electrode, Electrosurgical
What these counts are not
Clearance and recall counts are SPEQ’s aggregation of FDA’s own published records for the code. A recall count is a measure of history, not of a device’s safety, neither number is an FDA rating, and SPEQ is not affiliated with the FDA.
What this classification requires
Every statement below is FDA’s own classification record for this product code, quoted from the device classification field reference. The SPEQ reading beneath each one is SPEQ’s interpretation of what it means for the work, and is not FDA text.
510(K)
SPEQ READINGA premarket notification under 21 CFR Part 807 Subpart E is the route for this code. The submission argues substantial equivalence to a legally marketed predicate, so the engineering question is which predicate the design can actually be compared against, and the evidence question is what testing supports that comparison.
Class II (moderate to high risk): general controls and special controls
SPEQ READINGSpecial controls are the distinguishing feature: performance standards, guidance documents, patient registries or postmarket surveillance named for the device type. Find the special controls before designing the test plan — they usually name the tests.
Device is eligible for The Voluntary Malfunction Summary Reporting Program
SPEQ READINGMalfunctions for this code may be reported in periodic summary form rather than as individual MDRs under 21 CFR Part 803. Eligibility is a property of the product code; using it is a decision the manufacturer makes and must be able to justify.
Not exempt due to Good Manufacturing Practice (GMP)/Quality System
SPEQ READINGThe full Quality Management System Regulation (21 CFR 820, incorporating ISO 13485:2016) applies, and is what an FDA inspection of this device will be conducted against.
Device is not implantable
SPEQ READINGNo implant-specific expectations attach from the classification itself.
Device is not used for life sustaining purposes
SPEQ READINGNo life-sustaining designation attaches to this code.
Device is a candidate for a third party review program
SPEQ READINGAn Accredited Person may conduct the 510(k) review instead of FDA. FDA still makes the clearance decision — third-party review changes who reviews, never who decides.
Other product codes under 21 CFR 878.4400
One regulation usually governs several product codes. These share this code’s regulation, and therefore its classification basis.
21 CFR 878.4400 — Electrosurgical cutting and coagulation device and accessories
The classification regulation for this product code, as published by the Office of the Federal Register. This is the regulation text itself — no SPEQ interpretation appears in it.
(a) Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
(b) Classification. Class II.
Source: Electronic Code of Federal Regulations, Title 21. 21 CFR is a work of the United States Government and is in the public domain. SPEQ read this section on October 22, 2026. CFR is amended continuously, so verify against the source before acting on it: read 21 CFR 878.4400 on eCFR →
Recent recalls
Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Portugal,and Hong-Kong are being notified.
Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Portugal,and Hong-Kong are being notified.
SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packagin
Testing conducted by the firm indicates that electrodes identified with certain part numbers may fall out from the electrosurgical pencil or handle presenting the potential for harm or injury to the patient and/or user.
Improper wire placement from the patient plate to the ESU connector plug results in an intermittent displacement connection.
Inaccurate temperature readings may be displayed by the device, actual temperature could be 2.5-3 degrees C higher than displayed.
CONMED received complaints of damage to the CS-023 electrodes shaft insulation which could result in burn marks on the shaft. If the shaft insulation is damaged in any way, it could increase the risk of patient burn.
During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the introducer device. This capacitive coupling could result in therm
Source: FDA device classification, 510(k)/PMA, and recall datasets. Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. Browse every product code SPEQ tracks →