510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863090Substantially Equivalent

Percu Guide I (Loop Type)

E-Z-EM, Inc, Westbury NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863090 is the FDA 510(k) clearance record for PERCU GUIDE I (LOOP TYPE), a class I device, cleared for E-Z-Em, Inc. on under FDA product code GDF (Guide, Needle, Surgical). FDA records list 56 510(k) clearances for E-Z-Em, Inc., from to . As of , FDA records show no recalls naming K863090.

Clearance record

Decision date
Received
(16 days to decision)
Product code
GDF Guide, Needle, Surgical
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
E-Z-Em, Inc. 717 Main St., Westbury NY
Third party review
No

Clearances, product code GDF

Trailing 12 months

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

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