COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH— 510(k) K942573

Name: FDA 510(k) clearance K942573
Creator: U.S. Food and Drug Administration
Published: 1994-07-18

Substantially Equivalent

Richard Hamer Assoc., Inc.

FDA 510(k) clearance K942573 for COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH, Substantially Equivalent on 1994-07-18. Applicant: Richard Hamer Assoc., Inc.. Device class: 2.

Clearance details

Applicant: Richard Hamer Assoc., Inc.
Product code: Code FED
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1994-05-31
Decision date: 1994-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

Download summary PDF View on FDA.gov ↗

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K951325 — COMFEEL PLUS PRESSURE RELIEF DRESSING1995-07-31
K950934 — MPM HYDROGEL DRESSING1995-05-16
K951327 — COMFEEL PLUS CONTOUR DRESSING1995-04-28
K942283 — COMFEEL PLUS TRANSPARENT DRESSING1994-07-29

Adverse events under product code FED

product code FED

Death: 10
Total: 10

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.