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LRO — General Surgery Tray Class II

FDA Device Classification

FDA product code LRO covers "General Surgery Tray", a Class II medical device regulated under 21 CFR 878.4370. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
LRO
Device Class
Class II
Regulation Number
878.4370
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K213481medline industriesMedline General Surgery TrayMay 24, 2022
K212258medline industriesMedline Cardiovascular Procedure KitDecember 3, 2021
K041080d.i.r.r.aSURGICAL DRAPE KIT - D.I.R.R.A. SRLNovember 30, 2004
K030721ballard medical productsQUICK-TAP PARACENTESIS TRAY, KIT & NEEDLEMarch 31, 2003
K023276amsino internationalAMSINO TRACHEOSTOMY CARE TRAYDecember 9, 2002
K980137worldwide medical technologiesWORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAYJanuary 30, 1998
K971061opportunityOPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAYJune 11, 1997
K971062opportunityOPPORTUNITY INC. GENERAL PURPOSE TRAYJune 9, 1997
K932221associated medical productsNEUROLOGICAL OR CRANI TRAYS (PACKS)March 19, 1997
K970286medline industriesPRESBYTERIAN LINEN SERVICES SURGICAL PACKSMarch 10, 1997
K970187gi supplyRUNYON LARGE VOLUME PARACENTESIS KITFebruary 14, 1997
K965201trinity laboratoriesO.R. SCRUB PREP TRAY, STERILE, DISPOSABLEFebruary 14, 1997
K964921trinity laboratoriesBASIC BIOPSY TRAY. DISPOSABLE, STERILEJanuary 22, 1997
K963721grand medical productsSKIN SCRUB TRAYNovember 27, 1996
K963715grand medical productsDEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAYNovember 27, 1996
K964011customedSUCTION CATHETER TRAY PRODUCT NO. 900277November 25, 1996
K963443continental medical laboratoriesPROD. NO. 02-031 - LACERATION TRAYOctober 17, 1996
K962826medline industriesMEDLINE RADIOLOGY-DIAGNOSTIC KITSSeptember 16, 1996
K961863tri-medPARACENTESIS TRAYSMay 28, 1996
K953083hospital laundry servicesHOSPITAL LAUNDRY SERVICES SURGICAL PACKSMay 14, 1996

FDA data resources