510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854857Substantially Equivalent

Scalpel, One-Piece, Disposable

Medelec Intl. Corp., Miami Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854857 is the FDA 510(k) clearance record for SCALPEL, ONE-PIECE, DISPOSABLE, a class I device, cleared for Medelec Intl. Corp. on under FDA product code GDX (Scalpel, One-Piece). FDA records list 15 510(k) clearances for Medelec Intl. Corp., from to . As of , FDA records show no recalls naming K854857.

Clearance record

Decision date
Received
(19 days to decision)
Product code
GDX Scalpel, One-Piece
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Medelec Intl. Corp. One Lincoln Rd., Suite 304, Miami Beach FL
Third party review
No

Clearances, product code GDX

Trailing 12 months

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

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