510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K760927Substantially Equivalent

Stoma Shield Adapter

Rudolfo T. Sanchez, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K760927 is the FDA 510(k) clearance record for STOMA SHIELD ADAPTER, a class I device, cleared for Rudolfo T. Sanchez on under FDA product code EXE (Protector, Ostomy). FDA records list one 510(k) clearance for Rudolfo T. Sanchez. As of , FDA records show no recalls naming K760927.

Clearance record

Decision date
Received
(90 days to decision)
Product code
EXE Protector, Ostomy
Regulation
21 CFR 876.5900
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Rudolfo T. Sanchez 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EXE

Trailing 12 months

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

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