510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LROClass II

General Surgery Tray

21 CFR 878.4370 / General, Plastic Surgery
FDA source (opens on fda.gov)

LRO is the FDA product code for General Surgery Tray, a class II device type, regulated under 21 CFR 878.4370. FDA's definition for this code reads: "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...". As of , FDA records hold 110 510(k) clearances under this code, the most recent dated , and 1,059 recalls.

Classification record

Product code
LRO
Device name
General Surgery Tray
FDA 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
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
FDA code 7
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
110
Ingested recalls
1,070

Clearances, product code LRO

By decision year
110 clearances under product code LRO with a decision year between 1984 and 2022, 1994 the highest year at 24.
Show the numbers
510(k) clearances under FDA product code LRO by decision year
YearClearances
19841
19852
198710
19886
198910
19905
19915
19923
199317
199424
19956
19968
19977
19981
20021
20031
20041
20211
20221

Applicants with the most clearances

Product code LRO
Applicants holding the most 510(k) clearances under product code LRO
ApplicantClearances
Carapace, Inc.6
Customed, Inc6
Cush Medical Products5
MEDLINE INDUSTRIES, LP - Northfield5
Associated Medical Products Co.3
Medsurg Industries, Inc.3
Surgipro, Inc.3
Tri-Med Specialties, Inc.3
American Healthcare Supply Co., Inc.2
Cypress Medical Products LLC2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 131 companies shown, in name order