STRYKER HUMMER II MICRODEBRIDER SYSTEM— 510(k) K972584

Substantially Equivalent

Stryker Endoscopy

FDA 510(k) clearance K972584 for STRYKER HUMMER II MICRODEBRIDER SYSTEM, Substantially Equivalent on 1997-10-01. Applicant: Stryker Endoscopy.

Clearance details

Applicant: Stryker Endoscopy
Product code: Code ERL
Advisory panel: Ear, Nose, Throat
Date received: 1997-07-10
Decision date: 1997-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

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Adverse events under product code ERL

product code ERL

Malfunction: 11,234
Total: 11,234

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.