510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K892069Substantially Equivalent

Extended Covers, Sterile

Amedic USA, Sweden, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892069 is the FDA 510(k) clearance record for EXTENDED COVERS, STERILE, a class I device, cleared for Amedic USA on under FDA product code FFF (Cover, Biopsy Forceps). FDA records list 10 510(k) clearances for Amedic USA, from to . As of , FDA records show no recalls naming K892069.

Clearance record

Decision date
Received
(130 days to decision)
Product code
FFF Cover, Biopsy Forceps
Regulation
21 CFR 876.1075
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Amedic USA Oxenstiernsgatan 31, Sweden, SE
Third party review
No

Clearances, product code FFF

Trailing 12 months

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

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