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

Corkscrew

21 CFR 888.4540 / Orthopedic
FDA source (opens on fda.gov)

HWI is the FDA product code for Corkscrew, a class I device type, regulated under 21 CFR 888.4540. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
HWI
Device name
Corkscrew
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code HWI

By decision year
1 clearance under product code HWI with a decision year between 1988 and 1988, 1988 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HWI by decision year
YearClearances
19881

Applicants with the most clearances

Product code HWI
Applicants holding the most 510(k) clearances under product code HWI
ApplicantClearances
Baxter Healthcare Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 32 companies shown, in name order