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FDA product code · Obstetrics/Gynecology · Class 2

HET: Laparoscope, Gynecologic (And Accessories)

HET is FDA's product code for "Laparoscope, Gynecologic (And Accessories)": a Class 2 device classified under 21 CFR 884.1720, reviewed by the Obstetrics/Gynecology panel.

510(k) review time for HET

Across 12 510(k) clearances under HET decided from 2018-01-01 to 2026-10-06, the median was 182 days from FDA receipt to decision. Half took between 149 and 268 days, and 80% were decided within 269 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, HET, decisions 2018-01-01 to 2026-10-06 (n = 12)
Fastest24
25th percentile149
Median182
75th percentile268
80th percentile269
90th percentile273
Slowest442

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.

HET in the public FDA record

Records naming HET, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years338
Device recalls19
Establishment listings432
GUDID device identifiers2,597

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

12 FDA recognized consensus standards cite HET, 1 of them recognized only in part, among them ISO 8600-1 Fourth Edition 2015-10-15; ISO 8600-3 Second edition 2019-08; CIE ISO 11664-1:2019. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 9-110 ISO 8600-1 Fourth Edition 2015-10-15 — Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements
  • 9-123 ISO 8600-3 Second edition 2019-08 (partial recognition) — Endoscopes - Medical endoscopes and endotherapy devices Part 3: Determination of field of view and direction of view of endoscopes with optics.
  • 9-124 CIE ISO 11664-1:2019 — Colorimetry - Part 1: CIE standard colorimetric observers
  • 9-126 ISO CIE 11664-3 First edition 2019-06 — Colorimetry - Part 3: CIE tristimulus values
  • 9-127 ISO CIE 11664-4 First edition 2019-06 — Colorimetry - Part 4: CIE 1976 L*a*b* colour space
  • 9-129 ISO CIE 61966-2-1 First edition 1999-10 — Multimedia systems and equipment - Colour measurement and management - Part 2-1: Colour management - Default RGB colour space - sRGB [Including: Amendment 1 (2003) and Corrigendum 1 (2014)]
  • 9-130 ISO 8600-6 Second edition 2020-09 — Endoscopes - Medical endoscopes and endotherapy devices - Part 6: Vocabulary
  • 9-131 ISO 8600-5 Second Edition 2020-10 — Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics
  • 9-139 CIE ISO 11664-5:2016 — Colorimetry - Part 5: CIE 1976 L*u*v* colour space and u'v' uniform chromaticity scale diagram
  • 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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