510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K930763Substantially Equivalent

Figleaf Shield

Byers Industries, Inc., Portland OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930763 is the FDA 510(k) clearance record for FIGLEAF SHIELD, a class I device, cleared for Byers Industries, Inc. on under FDA product code IWT (Shield, Gonadal). FDA records list one 510(k) clearance for Byers Industries, Inc. As of , FDA records show no recalls naming K930763.

Clearance record

Decision date
Received
(94 days to decision)
Product code
IWT Shield, Gonadal
Regulation
21 CFR 892.6500
Device class
Class I
Review panel
Radiology
Applicant
Byers Industries, Inc. 6955 SW Sandburg St., Portland OR
510(k) summary
Statement
Third party review
No

Clearances, product code IWT

Trailing 12 months

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

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