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Scoping review

FDA product code · General, Plastic Surgery · Class 2

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

NUJ is FDA's product code for "Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed": a Class 2 device classified under 21 CFR 878.4400, reviewed by the General, Plastic Surgery panel.

510(k) review time for NUJ

Across 12 510(k) clearances under NUJ decided from 2018-01-01 to 2026-10-06, the median was 95 days from FDA receipt to decision. Half took between 59 and 178 days, and 80% were decided within 182 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, NUJ, decisions 2018-01-01 to 2026-10-06 (n = 12)
Fastest41
25th percentile59
Median95
75th percentile178
80th percentile182
90th percentile248
Slowest350

Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.

NUJ in the public FDA record

Records naming NUJ, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years37
Device recalls20
GUDID device identifiers602

Counts of records, not of devices or events. Adverse event reports for NUJ are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.

FDA-recognized standards that cite NUJ

2 FDA recognized consensus standards cite NUJ, 1 of them recognized only in part, among them IEC 60601-2-2 Edition 6.0 2017-03; IEC 60601-2-2 Edition 6.1 2023-02 CONSOLIDATED VERSION Corrected Version 2025-11. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 6-389 IEC 60601-2-2 Edition 6.0 2017-03 (partial recognition) — Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
  • 6-521 IEC 60601-2-2 Edition 6.1 2023-02 CONSOLIDATED VERSION Corrected Version 2025-11 — Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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