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Scoping review

FDA product code · Gastroenterology, Urology · Class 2

FDS: Gastroscope And Accessories, Flexible/Rigid

FDS is FDA's product code for "Gastroscope And Accessories, Flexible/Rigid": a Class 2 device classified under 21 CFR 876.1500, reviewed by the Gastroenterology, Urology panel.

510(k) review time for FDS

Across 43 510(k) clearances under FDS decided from 2018-01-01 to 2026-10-06, the median was 167 days from FDA receipt to decision. Half took between 82 and 230 days, and 80% were decided within 238 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, FDS, decisions 2018-01-01 to 2026-10-06 (n = 43)
Fastest24
25th percentile82
Median167
75th percentile230
80th percentile238
90th percentile266
Slowest357
Median days by decision year, FDS (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
20181676
20191755
2021785
20242205
20252118
2026 (to 10-06, partial)1647

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.

FDS in the public FDA record

Records naming FDS, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years78
Device recalls12
Establishment listings213
GUDID device identifiers625

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

3 FDA recognized consensus standards cite FDS, 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; ISO 8600-4 Third Edition 2023-01. 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
  • 9-146 ISO 8600-4 Third Edition 2023-01 — Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion

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

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