NUJClass II

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

21 CFR 878.4400 / General, Plastic Surgery

NUJ is the FDA product code for Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed, a class II device type, regulated under 21 CFR 878.4400. FDA's definition for this code reads: "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)". As of 2026-09-10, FDA records hold 37 510(k) clearances under this code, the most recent dated 2024-04-29, and 20 recalls.

Classification record

Product code: NUJ
Device name: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
FDA 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).
Regulation: 21 CFR 878.4400
Device class: Class II
Review panel: General, Plastic Surgery
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 37
Ingested recalls: 20

Clearances, product code NUJ

By decision year

37 clearances under product code NUJ with a decision year between 2001 and 2024, 2018 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code NUJ by decision year
Year	Clearances
2001	2
2005	1
2006	3
2008	1
2010	1
2011	2
2012	2
2013	2
2014	1
2015	2
2016	5
2017	3
2018	7
2019	1
2022	2
2023	1
2024	1

Applicants with the most clearances

Product code NUJ

Applicants holding the most 510(k) clearances under product code NUJ
Applicant	Clearances
Stryker Sustainability Solutions	10
Sterilmed Inc	7
Medline ReNewal	4
ReNovo, Inc.	3
Suretek Medical	3
Surgical Instrument Service and Savings Inc.(Dba Medline Ren	2
Surgical Instrument Services and Savings, Inc.	2
Alliance Medical Corp.	1
Medtronic, Inc.	1
Green or, LLC	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order