510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K882673Substantially Equivalent

Sigma 1 Wobbler Biopsy Kit

Kontron Instruments, Inc., Everett MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882673 is the FDA 510(k) clearance record for SIGMA 1 WOBBLER BIOPSY KIT, a class I device, cleared for Kontron Instruments, Inc. on under FDA product code FCH (Tray, Biopsy, Without Biopsy Instruments). FDA records list 58 510(k) clearances for Kontron Instruments, Inc., from to . As of , FDA records show no recalls naming K882673.

Clearance record

Decision date
Received
(30 days to decision)
Product code
FCH Tray, Biopsy, Without Biopsy Instruments
Regulation
21 CFR 876.4730
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Kontron Instruments, Inc. 9 Plymouth St., Everett MA
Third party review
No

Clearances, product code FCH

Trailing 12 months

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

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