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Ambler Surgical

Model Drews cystotome cannula · AMBLER SURGICAL CORP. · DI 00190660003821

HNY — Cystotome · Class I · 21 CFR 886.4350

UDILibrary device dossier · generated 2026-09-11 · 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.

23562022-08: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 6/device08091112101108070405
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2022-0801
2022-0901
2022-1101
2022-1201
2023-1001
2023-1101
2024-0801
2025-0701
2026-0401
2026-0506
This device (reports/month)Average device in HNY (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — AMBLER SURGICAL CORP.

Nothing in the loaded window.