510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K071307Substantially Equivalent

Invirolink and Inviro Tip Blunt Cannulas, Model 130001, 130501, 140001, 140002, 140003

Inviro Medical Devices, Inc., Duluth GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071307 is the FDA 510(k) clearance record for INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003, a class II device, cleared for Inviro Medical Devices, Inc. on under FDA product code FMI (Needle, Hypodermic, Single Lumen). FDA records list 7 510(k) clearances for Inviro Medical Devices, Inc., from to . As of , FDA records show no recalls naming K071307.

Clearance record

Decision date
Received
(279 days to decision)
Product code
FMI Needle, Hypodermic, Single Lumen
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Inviro Medical Devices, Inc. 3235 Satellite Blvd., Duluth GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FMI

Trailing 12 months
13 clearances under product code FMI in the twelve months to October 2026, March 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code FMI, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20263
April 20261
May 20260
June 20261
July 20262
August 20263
September 20261
October 20260