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FDA product code · Gastroenterology, Urology · Class 2

FDI: Snare, Flexible

FDI is FDA's product code for "Snare, Flexible": a Class 2 device classified under 21 CFR 876.4300, reviewed by the Gastroenterology, Urology panel.

510(k) review time for FDI

Across 16 510(k) clearances under FDI decided from 2018-01-01 to 2026-10-06, the median was 209 days from FDA receipt to decision. Half took between 78 and 256 days, and 80% were decided within 263 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, FDI, decisions 2018-01-01 to 2026-10-06 (n = 16)
Fastest29
25th percentile78
Median209
75th percentile256
80th percentile263
90th percentile265
Slowest267

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.

FDI in the public FDA record

Records naming FDI, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years63
Device recalls18
Establishment listings134
GUDID device identifiers599

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

2 FDA recognized consensus standards cite FDI, 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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