510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K833837Substantially Equivalent

American Gold Series Autoclave

Tuttnauer Ltd., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833837 is the FDA 510(k) clearance record for AMERICAN GOLD SERIES AUTOCLAVE, a class II device, cleared for Tuttnauer Co. , Ltd. on under FDA product code FLE (Sterilizer, Steam). FDA records list 10 510(k) clearances for Tuttnauer Co. , Ltd., from to . As of , FDA records show no recalls naming K833837.

Clearance record

Decision date
Received
(69 days to decision)
Product code
FLE Sterilizer, Steam
Regulation
21 CFR 880.6880
Device class
Class II
Review panel
General Hospital
Applicant
Tuttnauer Co. , Ltd. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code FLE

Trailing 12 months
4 clearances under product code FLE in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FLE, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20261
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260