510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K921727Substantially Equivalent

Core Monitoring System-Sp1475/6275/5607/5708/4575

Viggo-Spectramed, Oxnard CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921727 is the FDA 510(k) clearance record for CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575, a class II device, cleared for Viggo-Spectramed on under FDA product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)). FDA records list one 510(k) clearance for Viggo-Spectramed. As of , FDA records show no recalls naming K921727.

Clearance record

Decision date
Received
(760 days to decision)
Product code
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Regulation
21 CFR 884.4160
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Viggo-Spectramed 1900 Williams Dr., Oxnard CA
510(k) summary
Statement
Third party review
No

Clearances, product code KNF

Trailing 12 months
1 clearance under product code KNF in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNF, 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 20261
October 20260