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NUJ

Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

Product code
NUJ
Device name
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Device class
Class 2
21 CFR
21 CFR 878.4400
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
37 (all years; only the last 3 years are listed here)

FDA classification definition

Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-04-29.

NumberDecision dateApplicantDevice nameSummary
K2325112024-04-29Surgical Instrument Service and Saving…Medline ReNewal Reprocessed LigaSure Exact Dissector…PDF

1 summaries are archived here for direct download.

Official FDA classification page: NUJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).