O.R. BASIN SET TRAY— 510(k) K935741

Name: FDA 510(k) clearance K935741
Creator: U.S. Food and Drug Administration
Published: 1994-02-15

Substantially Equivalent

Cush Medical Products

FDA 510(k) clearance K935741 for O.R. BASIN SET TRAY, Substantially Equivalent on 1994-02-15. Applicant: Cush Medical Products. Device class: 2.

Clearance details

Applicant: Cush Medical Products
Product code: Code LRO
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1993-12-01
Decision date: 1994-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Piney Flats, TN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Cush Medical Products

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K943424 — CUSH ISLAND DRESSING1994-10-03
K940518 — C-SECTION TRAY1994-08-18
K941349 — DENTAL TRAY1994-07-26
K941645 — BIOPSY TRAY1994-07-14
K940239 — EYE TRAY1994-06-28

Adverse events under product code LRO

product code LRO

Injury: 975
Malfunction: 14,038
Other: 2
Total: 15,015

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.