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

Snake Bite Suction Kit

21 CFR 880.5740 / General Hospital
FDA source (opens on fda.gov)

KYP is the FDA product code for Snake Bite Suction Kit, a class I device type, regulated under 21 CFR 880.5740. 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 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KYP
Device name
Snake Bite Suction Kit
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 880.5740
Device class
Class I
Review panel
General Hospital
Submission type
FDA code 7
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code KYP

By decision year
4 clearances under product code KYP with a decision year between 1983 and 1988, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KYP by decision year
YearClearances
19831
19841
19851
19881

Applicants with the most clearances

Product code KYP
Applicants holding the most 510(k) clearances under product code KYP
ApplicantClearances
Chiron Vision Corp.1
Marlo Surgical Technology1
Medie Group1
Saffeta, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order