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
K801349Substantially Equivalent

Loseff Balloon Type Self-Retention Wound

Loseff Medical Designers, Ltd., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801349 is the FDA 510(k) clearance record for LOSEFF BALLOON TYPE SELF-RETENTION WOUND, a class II device, cleared for Loseff Medical Designers, Ltd. on under FDA product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered). FDA records list 2 510(k) clearances for Loseff Medical Designers, Ltd., from to . As of , FDA records show no recalls naming K801349.

Clearance record

Decision date
Received
(59 days to decision)
Product code
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Regulation
21 CFR 878.4780
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Loseff Medical Designers, Ltd. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JCX

Trailing 12 months
1 clearance under product code JCX in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JCX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260