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

Operating Room Accessories Table Tray

21 CFR 878.4950 / General, Plastic Surgery
FDA source (opens on fda.gov)

FWZ is the FDA product code for Operating Room Accessories Table Tray, a class I device type, regulated under 21 CFR 878.4950. 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 61 510(k) clearances under this code, the most recent dated , and 37 recalls.

Classification record

Product code
FWZ
Device name
Operating Room Accessories Table 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 878.4950
Device class
Class I
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
61
Ingested recalls
37

Clearances, product code FWZ

By decision year
61 clearances under product code FWZ with a decision year between 1976 and 1996, 1987 the highest year at 20.
Show the numbers
510(k) clearances under FDA product code FWZ by decision year
YearClearances
19761
19791
19802
19811
19825
19835
19844
19864
198720
19883
19893
19902
19913
19933
19943
19961

Applicants with the most clearances

Product code FWZ
Applicants holding the most 510(k) clearances under product code FWZ
ApplicantClearances
Mcconnell Orthopedic14
Mizuho Orthopedic Systems Inc8
D.L. Nelson and Assoc., Inc.3
American Container Technology, Inc.2
Devon Industries, Inc.2
Edgewater Medical Equipment Systems2
Lincoln Mills, Inc.2
The Anspach Effort, Inc.2
3M Company1
Acufex Microsurgical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 140 companies shown, in name order