BRADBURY INTRAOCULAR RETINAL KIT CAT #200— 510(k) K881049

Name: FDA 510(k) clearance K881049
Creator: U.S. Food and Drug Administration
Published: 1988-09-12

Substantially Equivalent

Microline Pentax, Inc.

FDA 510(k) clearance K881049 for BRADBURY INTRAOCULAR RETINAL KIT CAT #200, Substantially Equivalent on 1988-09-12. Applicant: Microline Pentax, Inc.. Device class: 1.

Clearance details

Applicant: Microline Pentax, Inc.
Product code: Code HNR
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1988-03-11
Decision date: 1988-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Devers, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HNR

product code HNR

Malfunction: 497
Other: 1
Total: 498

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.