10xAnd
Scoping review

FDA product code · General, Plastic Surgery · Class 2

NEW: Suture, Surgical, Absorbable, Polydioxanone

NEW is FDA's product code for "Suture, Surgical, Absorbable, Polydioxanone": a Class 2 device classified under 21 CFR 878.4840, reviewed by the General, Plastic Surgery panel. FDA flags it as an implant.

510(k) review time for NEW

Across 27 510(k) clearances under NEW decided from 2018-01-01 to 2026-10-06, the median was 204 days from FDA receipt to decision. Half took between 104 and 298 days, and 80% were decided within 327 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, NEW, decisions 2018-01-01 to 2026-10-06 (n = 27)
Fastest27
25th percentile104
Median204
75th percentile298
80th percentile327
90th percentile373
Slowest556
Median days by decision year, NEW (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
20251466
2026 (to 10-06, partial)2645

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.

NEW in the public FDA record

Records naming NEW, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years66
Device recalls40
Establishment listings183
GUDID device identifiers3,548

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

6 FDA recognized consensus standards cite NEW, 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
  • 6-473 USP-NF M80190_04_01 — Absorbable Surgical Suture
  • 8-592 ASTM F3384-21 — Standard Specification for Polydioxanone Polymer Resins for Surgical Implants

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

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