510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K790186Substantially Equivalent

Protectivstabilizer

Jelco Laboratories, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K790186 is the FDA 510(k) clearance record for PROTECTIVSTABILIZER, a class I device, cleared for Jelco Laboratories on under FDA product code GBJ (Prosthesis, Adhesive, External). FDA records list 26 510(k) clearances for Jelco Laboratories, from to . As of , FDA records show no recalls naming K790186.

Clearance record

Decision date
Received
(28 days to decision)
Product code
GBJ Prosthesis, Adhesive, External
Regulation
21 CFR 878.3750
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Jelco Laboratories 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GBJ

Trailing 12 months

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

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