510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K855039Substantially Equivalent

Mediflex Injection Cap

Mediflex Intl., Pine Brook NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K855039 is the FDA 510(k) clearance record for MEDIFLEX INJECTION CAP, a class I device, cleared for Mediflex Intl. on under FDA product code GCE (Adaptor, Catheter). FDA records list 9 510(k) clearances for Mediflex Intl., from to . As of , FDA records show no recalls naming K855039.

Clearance record

Decision date
Received
(38 days to decision)
Product code
GCE Adaptor, Catheter
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Mediflex Intl. 30 Chapin Rd. Box 2007, Pine Brook NJ
Third party review
No

Clearances, product code GCE

Trailing 12 months

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

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