510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031173Substantially Equivalent

Needletech Guidewire Introducer Needle, Models 40021, 40069, 40053, 40042 & 40013

Needle Tech Products, Inc., Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031173 is the FDA 510(k) clearance record for NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013, a class I device, cleared for Needle Tech Products, Inc. on under FDA product code GDF (Guide, Needle, Surgical). FDA records list 3 510(k) clearances for Needle Tech Products, Inc., from to . As of , FDA records show no recalls naming K031173.

Clearance record

Decision date
Received
(100 days to decision)
Product code
GDF Guide, Needle, Surgical
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Needle Tech Products, Inc. 81 W. St., Attleboro MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GDF

Trailing 12 months

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

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