510(k) K842648 ยท LRO General Surgery Tray
GENERAL SURGERY TRAY
| Applicant | Deroyal Industries, Inc., Powell TN, US |
| Decision | Substantially Equivalent, Sep 20, 1984 |
| Received | Aug 13, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K842648
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 5, 2024 | DeRoyal Industries Inc DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06 Open, Classified |
LRO | None listed |
| Nov 5, 2024 | DeRoyal Industries Inc DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06 Open, Classified |
LRO | None listed |
| Sep 30, 2024 | DeRoyal Industries Inc DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572 Open, Classified |
LRO | None listed |
| Mar 29, 2024 | DeRoyal Industries Inc GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART Open, Classified |
LRO | None listed |
| Oct 16, 2023 | DeRoyal Industries Inc DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit Open, Classified |
LRO | None listed |
| Jul 3, 2023 | DeRoyal 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 |
LRO | None listed |
| Jun 7, 2023 | DeRoyal 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 |
LRO | None listed |
| Jan 9, 2023 | DeRoyal Industries Inc DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10 Terminated |
LRO | None listed |
| Aug 12, 2022 | DeRoyal Industries Inc DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors Terminated |
LRO | None listed |
| Mar 3, 2022 | DeRoyal 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 |
LRO | None listed |
| Mar 3, 2022 | DeRoyal 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 |
LRO | None listed |
| Sep 29, 2021 | Deroyal Industries, Inc. Lafollette DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set Terminated |
LRO | None listed |
| Jun 10, 2021 | DeRoyal Industries Inc DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06 Terminated |
LRO | None listed |
| Jan 25, 2021 | DeRoyal 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 |
LRO | None listed |
| Jan 25, 2021 | DeRoyal 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 |
LRO | None listed |
| Jan 25, 2021 | DeRoyal 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 |
LRO | None listed |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
Outpatient Major 89-3865.12; Terminated |
LRO | None listed |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
Chronic Ear Pack 89-4393.17 Terminated |
LRO | None listed |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
Shoulder Pack 89-4751.08 Terminated |
LRO | None listed |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
ASC General Pack 89-6015.16 Terminated |
LRO | None listed |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
Cystoscopy Pack 89-6071.15 Terminated |
LRO | None listed |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
ASC Laparoscopy Pack 89-6138.13 Terminated |
LRO | None listed |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
ASC Thyroid Pack 89-6302.14 Terminated |
LRO | None listed |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
Ophthalmology CSTM PCK 89-6387.08 Terminated |
LRO | None listed |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
Kwik Kit 89-6389.06 Terminated |
LRO | None listed |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
ASC Ocular Plastics Pack 89-6498.13 Terminated |
LRO | None listed |
| Jun 18, 2019 | DeRoyal Industries Inc DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07
custom surgical pack Terminated |
LRO | None listed |
| Jan 22, 2018 | DeRoyal 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 |
LRO | None listed |
| Dec 19, 2017 | DeRoyal 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 |
LRO | None listed |
| Oct 16, 2017 | DeRoyal 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 |
LRO | None listed |
| Jan 25, 2017 | DeRoyal Industries Inc DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN. Terminated |
LRO | None listed |
| Aug 26, 2016 | DeRoyal Industries Inc Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO,
Custom surgical kit. Terminated |
LRO | None listed |
| Aug 26, 2016 | DeRoyal Industries Inc DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O, Terminated |
LRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.