ClearanceBrief
510(k) K842648 ยท LRO General Surgery Tray

GENERAL SURGERY TRAY

ApplicantDeroyal Industries, Inc., Powell TN, US
DecisionSubstantially Equivalent, Sep 20, 1984
ReceivedAug 13, 1984
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K842648

DateFirm and productCodeLinked 510(k)
Nov 5, 2024DeRoyal Industries Inc
DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
Open, Classified
LRONone listed
Nov 5, 2024DeRoyal Industries Inc
DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
Open, Classified
LRONone listed
Sep 30, 2024DeRoyal Industries Inc
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
Open, Classified
LRONone listed
Mar 29, 2024DeRoyal Industries Inc
GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
Open, Classified
LRONone listed
Oct 16, 2023DeRoyal Industries Inc
DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
Open, Classified
LRONone listed
Jul 3, 2023DeRoyal Industries Inc
Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOULDER PACK, REF '89-10115; d) MINOR ORTHO PACK, REF '89-10213; e) T
Open, Classified
LRONone listed
Jun 7, 2023DeRoyal Industries Inc
Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital; (3) 89-10509.02, LAPAROTOMY PACK, Stone
Open, Classified
LRONone listed
Jan 9, 2023DeRoyal Industries Inc
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
Terminated
LRONone listed
Aug 12, 2022DeRoyal Industries Inc
DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
Terminated
LRONone listed
Mar 3, 2022DeRoyal Industries Inc
DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
Terminated
LRONone listed
Mar 3, 2022DeRoyal Industries Inc
DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
Terminated
LRONone listed
Sep 29, 2021Deroyal Industries, Inc. Lafollette
DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
Terminated
LRONone listed
Jun 10, 2021DeRoyal Industries Inc
DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06
Terminated
LRONone listed
Jan 25, 2021DeRoyal Industries Inc
CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.16 Custom surgical procedure packs including sternum saw blades.
Terminated
LRONone listed
Jan 25, 2021DeRoyal Industries Inc
Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum saw blades.
Terminated
LRONone listed
Jan 25, 2021DeRoyal Industries Inc
Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packs including sternum saw blades.
Terminated
LRONone listed
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;
Terminated
LRONone listed
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Chronic Ear Pack 89-4393.17
Terminated
LRONone listed
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08
Terminated
LRONone listed
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC General Pack 89-6015.16
Terminated
LRONone listed
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Cystoscopy Pack 89-6071.15
Terminated
LRONone listed
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Laparoscopy Pack 89-6138.13
Terminated
LRONone listed
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Thyroid Pack 89-6302.14
Terminated
LRONone listed
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmology CSTM PCK 89-6387.08
Terminated
LRONone listed
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Kwik Kit 89-6389.06
Terminated
LRONone listed
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13
Terminated
LRONone listed
Jun 18, 2019DeRoyal Industries Inc
DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack
Terminated
LRONone listed
Jan 22, 2018DeRoyal Industries Inc
Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy
Terminated
LRONone listed
Dec 19, 2017DeRoyal Industries Inc
DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows: (a) Shoulder Arthroscopy Pack 8
Terminated
LRONone listed
Oct 16, 2017DeRoyal Industries Inc
DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage Tray, REF 47-763.04 b) Incision and Drainage Tray, REF 47-763.06 c) Incision and Drainage Tr
Terminated
LRONone listed
Jan 25, 2017DeRoyal Industries Inc
DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
Terminated
LRONone listed
Aug 26, 2016DeRoyal Industries Inc
Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.
Terminated
LRONone listed
Aug 26, 2016DeRoyal Industries Inc
DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,
Terminated
LRONone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.