510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K955119Substantially Equivalent

Symbiosis Monopolar Electrosurgical Roller Electrodes

Boston Scientific Corporation, Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955119 is the FDA 510(k) clearance record for SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES, a class II device, cleared for Symbiosis Corp. on under FDA product code HIH (Hysteroscope (And Accessories)). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K955119.

Clearance record

Decision date
Received
(70 days to decision)
Product code
HIH Hysteroscope (And Accessories)
Regulation
21 CFR 884.1690
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Symbiosis Corp. 8600 NW 41 St., Miami FL
510(k) summary
Summary
Third party review
No

Clearances, product code HIH

Trailing 12 months
8 clearances under product code HIH in the twelve months to November 2026, September 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code HIH, trailing twelve months
MonthClearances
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20261
September 20263
October 20260
November 20260