510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K921386Substantially Equivalent

Suop Electrodes for Excisional Procedures

Silver Creek Surgical, Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921386 is the FDA 510(k) clearance record for SUOP ELECTRODES FOR EXCISIONAL PROCEDURES, a class II device, cleared for Silver Creek Surgical on under FDA product code HGI (Electrocautery, Gynecologic (And Accessories)). FDA records list one 510(k) clearance for Silver Creek Surgical. As of , FDA records show no recalls naming K921386.

Clearance record

Decision date
Received
(564 days to decision)
Product code
HGI Electrocautery, Gynecologic (And Accessories)
Regulation
21 CFR 884.4120
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Silver Creek Surgical 1963 Rock St., Mountain View CA
510(k) summary
Statement
Third party review
No

Clearances, product code HGI

Trailing 12 months

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

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