510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K000533Substantially Equivalent

Vocom Implant- 8Mm

Smith & Nephew, Inc., Bartlett TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000533 is the FDA 510(k) clearance record for VOCOM IMPLANT- 8MM, a class II device, cleared for Smith & Nephew, Inc. on under FDA product code MIX (System, Vocal Cord Medialization). FDA records list 572 510(k) clearances for Smith & Nephew, Inc., from to . As of , FDA records show no recalls naming K000533.

Clearance record

Decision date
Received
(13 days to decision)
Product code
MIX System, Vocal Cord Medialization
Regulation
21 CFR 874.3620
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Smith & Nephew, Inc. 2925 Appling Rd., Bartlett TN
510(k) summary
Summary
Third party review
No

Clearances, product code MIX

Trailing 12 months

FDA records hold no clearances under product code MIX in the trailing twelve months.

FDA records show no clearances under product code MIX in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MIX, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260