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
SUBSCRIBE / SIGN IN
K101563Substantially Equivalent

Smarto

Jeil Medical Corporation, Seoul, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101563 is the FDA 510(k) clearance record for SMARTO, a class I device, cleared for Jeil Medical Corporation on under FDA product code KIJ (Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment). FDA records list 53 510(k) clearances for Jeil Medical Corporation, from to . As of , FDA records show no recalls naming K101563.

Clearance record

Decision date
Received
(196 days to decision)
Product code
KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Jeil Medical Corporation 1006 Digital 2cha Valley, Seoul, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KIJ

Trailing 12 months

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

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