SURGI-SPRAY O.R. IRRIGATION SYSTEM— 510(k) K913568

Name: FDA 510(k) clearance K913568
Creator: U.S. Food and Drug Administration
Published: 1991-11-01

Substantially Equivalent

Phoenix Surgical Products, Inc.

FDA 510(k) clearance K913568 for SURGI-SPRAY O.R. IRRIGATION SYSTEM, Substantially Equivalent on 1991-11-01. Applicant: Phoenix Surgical Products, Inc.. Device class: 2.

Clearance details

Applicant: Phoenix Surgical Products, Inc.
Product code: Code FQH
Device class: Class 2
Regulation: 21 CFR 880.5475
Advisory panel: General Hospital
Date received: 1991-08-09
Decision date: 1991-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, US

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Adverse events under product code FQH

product code FQH

Injury: 170
Malfunction: 2,513
Other: 1
Total: 2,684

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.