510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K912632Substantially Equivalent

Occlude

Pascal International, Inc., Bellevue WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912632 is the FDA 510(k) clearance record for OCCLUDE, a class I device, cleared for Pascal Co., Inc. on under FDA product code EFH (Paper, Articulation). FDA records list 8 510(k) clearances for Pascal International, Inc., from to . As of , FDA records show no recalls naming K912632.

Clearance record

Decision date
Received
(217 days to decision)
Product code
EFH Paper, Articulation
Regulation
21 CFR 872.6140
Device class
Class I
Review panel
Dental
Applicant
Pascal Co., Inc. P.O. Box 1478, Bellevue WA
510(k) summary
Statement
Third party review
No

Clearances, product code EFH

Trailing 12 months

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

FDA records show no clearances under product code EFH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EFH, 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