RIZA-RIBE NEEDLE— 510(k) K953441

Name: FDA 510(k) clearance K953441
Creator: U.S. Food and Drug Administration
Published: 1995-08-18

Substantially Equivalent

R-Med, Inc.

FDA 510(k) clearance K953441 for RIZA-RIBE NEEDLE, Substantially Equivalent on 1995-08-18. Applicant: R-Med, Inc.. Device class: 2.

Clearance details

Applicant: R-Med, Inc.
Product code: Code FBK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1995-07-17
Decision date: 1995-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oregon, OH, US

Download summary PDF View on FDA.gov ↗

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More clearances from R-Med, Inc.

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K001236 — RIZA BAND STRETCHER (RBS)-600002000-07-17
K953360 — R-MED ABDOMINAL WALL ELEVATOR1996-01-11
K954882 — RIZA-RIBE NEEDLE (MODIFICATION)1995-11-16
K950108 — R-MED MINI-RETRACTOR1995-05-11
K942411 — R-MED DISPOSABLE PLUG1995-03-31

Adverse events under product code FBK

product code FBK

Other: 1
Total: 1

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.