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FDA product code · Gastroenterology, Urology · Class 2

KGE: Forceps, Biopsy, Electric

KGE is FDA's product code for "Forceps, Biopsy, Electric": a Class 2 device classified under 21 CFR 876.4300, reviewed by the Gastroenterology, Urology panel.

510(k) review time for KGE

Across 11 510(k) clearances under KGE decided from 2018-01-01 to 2026-10-06, the median was 202 days from FDA receipt to decision. Half took between 174 and 251 days, and 80% were decided within 258 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, KGE, decisions 2018-01-01 to 2026-10-06 (n = 11)
Fastest29
25th percentile174
Median202
75th percentile251
80th percentile258
90th percentile264
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.

KGE in the public FDA record

Records naming KGE, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years46

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

2 FDA recognized consensus standards cite KGE, 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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