510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912128Substantially Equivalent

Maxi-Scope or Ultra-Scope

Seiichi Mfg., Inc., Jamestown KY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912128 is the FDA 510(k) clearance record for MAXI-SCOPE OR ULTRA-SCOPE, a class I device, cleared for Seiichi Mfg., Inc. on under FDA product code LDE (Stethoscope, Manual). FDA records list one 510(k) clearance for Seiichi Mfg., Inc. As of , FDA records show no recalls naming K912128.

Clearance record

Decision date
Received
(45 days to decision)
Product code
LDE Stethoscope, Manual
Regulation
21 CFR 870.1875
Device class
Class I
Review panel
Cardiovascular
Applicant
Seiichi Mfg., Inc. 95 Riverside Dr., Jamestown KY
510(k) summary
Statement
Third party review
No

Clearances, product code LDE

Trailing 12 months

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

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