510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K931793Substantially Equivalent

Symbiosis ENT Surgical Instruments

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

K931793 is the FDA 510(k) clearance record for SYMBIOSIS ENT SURGICAL INSTRUMENTS, a class I device, cleared for Symbiosis Corp. on under FDA product code LRC (Instrument, Ent Manual Surgical). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K931793.

Clearance record

Decision date
Received
(101 days to decision)
Product code
LRC Instrument, Ent Manual Surgical
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Symbiosis Corp. 8600 NW 41 St., Miami FL
510(k) summary
Summary
Third party review
No

Clearances, product code LRC

Trailing 12 months

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

FDA records show no clearances under product code LRC in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LRC, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260