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FDA product code · General, Plastic Surgery · Class 2

GAT: Suture, Nonabsorbable, Synthetic, Polyethylene

GAT is FDA's product code for "Suture, Nonabsorbable, Synthetic, Polyethylene": a Class 2 device classified under 21 CFR 878.5000, reviewed by the General, Plastic Surgery panel. FDA flags it as an implant.

510(k) review time for GAT

Across 45 510(k) clearances under GAT decided from 2018-01-01 to 2026-10-06, the median was 121 days from FDA receipt to decision. Half took between 59 and 214 days, and 80% were decided within 246 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, GAT, decisions 2018-01-01 to 2026-10-06 (n = 45)
Fastest27
25th percentile59
Median121
75th percentile214
80th percentile246
90th percentile284
Slowest643
Median days by decision year, GAT (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
2018956
20202015
20221095
20232208
2025305
2026 (to 10-06, partial)835

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.

GAT in the public FDA record

Records naming GAT, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years176
Device recalls23
Establishment listings1,012
GUDID device identifiers9,356

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

4 FDA recognized consensus standards cite GAT, among them USP-NF M80200_04_01; USP-NF M99670_02_01; USP-NF M99650_02_01. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 6-467 USP-NF M80200_04_01 — Nonabsorbable Surgical Suture
  • 6-468 USP-NF M99670_02_01 — <881> Tensile Strength
  • 6-469 USP-NF M99650_02_01 — <861> Sutures - Diameter
  • 6-470 USP-NF M99660_03_01 — <871> Sutures - Needle Attachment

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

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