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Switchpoint Infinity

Model 0678001400 · STRYKER COMMUNICATIONS INC. · DI 07613327303605

OCS — Endoscopic Video Imaging System/Component, Gastroenterology-Urology · Class II · 21 CFR 876.1500

UDILibrary device dossier · generated 2026-09-06 · 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.

01112023-09: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1/device0903
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2023-0901
2024-0301
This device (reports/month)Average device in OCS (reports/device/month)

Regulatory clearances

  • K100852 SESE 2010-05-06 (k number procode)

Manufacturer compliance record — STRYKER COMMUNICATIONS INC.

  • NAI 2016-03-03 Stryker Communications · 0 citations
  • NAI 2012-11-13 Stryker Communications · 0 citations
  • VAI 2012-03-02 Stryker Communications · 2 citations