510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901922Substantially Equivalent

Safte Orione Hernia Belt Items No. 316, 515, 536

Safte S.p.A., Italia, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901922 is the FDA 510(k) clearance record for SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536, a class I device, cleared for Safte S.P.A. on under FDA product code EXN (Support, Hernia). FDA records list one 510(k) clearance for Safte S.P.A. As of , FDA records show no recalls naming K901922.

Clearance record

Decision date
Received
(179 days to decision)
Product code
EXN Support, Hernia
Regulation
21 CFR 876.5970
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Safte S.P.A. Via Trecate, 9/A, Italia, IT
Third party review
No

Clearances, product code EXN

Trailing 12 months

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

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