510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160101Substantially Equivalent

SinuBand

Bioinspire Technologies, Incorporated, Palo Alto CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160101 is the FDA 510(k) clearance record for SinuBand, a class I device, cleared for Bioinspire Technologies, Incorporated on under FDA product code QJL (Splint, Intranasal Septal, Cber Led). FDA's definition for product code QJL reads: "Splint, Intranasal Septal, CBER led". FDA records list one 510(k) clearance for Bioinspire Technologies, Incorporated. As of , FDA records show no recalls naming K160101.

Clearance record

Decision date
Received
(190 days to decision)
Product code
QJL Splint, Intranasal Septal, Cber Led
Regulation
21 CFR 874.4780
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Bioinspire Technologies, Incorporated 2450 Embarcadero Way, Palo Alto CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QJL

Trailing 12 months

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

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