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Anovo Instrument ARM Curved Scissors

Model - · MOMENTIS SURGICAL LTD · DI 17290018151348

QNM — Mountable Electromechanical Surgical System For Transluminal Approaches · Class II · 21 CFR 878.4961

UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

01112022-03: 0 reports for this device; peer average 1/device03
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2022-0301
This device (reports/month)Average device in QNM (reports/device/month)

Regulatory clearances

  • K251761 SESE 2025-07-08 (k number procode)
  • K251056 SESE 2025-05-02 (k number procode)
  • K243182 SESE 2025-02-03 (k number procode)

Predicate lineage

K243182 — cites (transitively): DEN190022 (d1) — cited as predicate by K251056, K251761

K251056 — cites (transitively): K243182 (d1), DEN190022 (d2) — cited as predicate by K251761

K251761 — cites (transitively): K241907 (d1), K242157 (d1), K243182 (d1), K250591 (d1), K251056 (d1), DEN190022 (d2), K232146 (d2), K233312 (d2), K200473 (d3), K171947 (d4), K972699 (d4) — cited as predicate by K260804

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — MOMENTIS SURGICAL LTD

Nothing in the loaded window.