510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K072051Substantially Equivalent

Novatome, Model: Su101-50

Scholten Surgical Instruments, Inc., Lodi CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K072051 is the FDA 510(k) clearance record for NOVATOME, MODEL: SU101-50, a class II device, cleared for Scholten Surgical Instruments, Inc. on under FDA product code DWZ (Device, Biopsy, Endomyocardial). FDA records list 8 510(k) clearances for Scholten Surgical Instruments, Inc., from to . As of , FDA records show no recalls naming K072051.

Clearance record

Decision date
Received
(69 days to decision)
Product code
DWZ Device, Biopsy, Endomyocardial
Regulation
21 CFR 870.4075
Device class
Class II
Review panel
Cardiovascular
Applicant
Scholten Surgical Instruments, Inc. 170 Commerce St. # 101, Lodi CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DWZ

Trailing 12 months

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

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