510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K802286Substantially Equivalent

Argle Latex Penrose Tubing

Sherwood Medical Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802286 is the FDA 510(k) clearance record for ARGLE LATEX PENROSE TUBING, a class I device, cleared for Sherwood Medical Co. on under FDA product code KGZ (Accessories, Catheter). FDA records list 191 510(k) clearances for Sherwood Medical Co., from to . As of , FDA records show no recalls naming K802286.

Clearance record

Decision date
Received
(34 days to decision)
Product code
KGZ Accessories, Catheter
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Sherwood Medical Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KGZ

Trailing 12 months

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

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