510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863213Substantially Equivalent

Keisei Scalpel (Sterile and Non-Sterile)

Keisei Medical Industrial Co., Ltd., Bethel CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863213 is the FDA 510(k) clearance record for KEISEI SCALPEL (STERILE AND NON-STERILE), a class I device, cleared for Keisei Medical Industrial Co., Ltd. on under FDA product code GDX (Scalpel, One-Piece). FDA records list 4 510(k) clearances for Keisei Medical Industrial Co., Ltd. As of , FDA records show no recalls naming K863213.

Clearance record

Decision date
Received
(13 days to decision)
Product code
GDX Scalpel, One-Piece
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Keisei Medical Industrial Co., Ltd. 9 Autumn Dr., Bethel CT
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