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FDA product code · Gastroenterology, Urology · Class 2

NEZ: System, Imaging, Gastrointestinal, Wireless, Capsule

NEZ is FDA's product code for "System, Imaging, Gastrointestinal, Wireless, Capsule": a Class 2 device classified under 21 CFR 876.1300, reviewed by the Gastroenterology, Urology panel.

510(k) review time for NEZ

Across 14 510(k) clearances under NEZ decided from 2018-01-01 to 2026-10-06, the median was 130 days from FDA receipt to decision. Half took between 99 and 175 days, and 80% were decided within 203 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, NEZ, decisions 2018-01-01 to 2026-10-06 (n = 14)
Fastest85
25th percentile99
Median130
75th percentile175
80th percentile203
90th percentile253
Slowest351

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.

NEZ in the public FDA record

Records naming NEZ, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years47

Counts of records, not of devices or events. Adverse event reports for NEZ 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 NEZ

3 FDA recognized consensus standards cite NEZ, among them ISO 8600-4 Third Edition 2023-01; ISO CIE 11664-2 First edition 2022-08; ISO CIE 11664-6 Second edition 2022-08. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 9-146 ISO 8600-4 Third Edition 2023-01 — Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
  • 9-147 ISO CIE 11664-2 First edition 2022-08 — Colorimetry - Part 2: CIE standard illuminants
  • 9-148 ISO CIE 11664-6 Second edition 2022-08 — Colorimetry - Part 6: CIEDE2000 colour-difference formula

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

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