510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K974327Substantially Equivalent

Winged Needle Holder

Phx Technologies Corp., Denton TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974327 is the FDA 510(k) clearance record for WINGED NEEDLE HOLDER, a class I device, cleared for Phx Technologies Corp. on under FDA product code FHQ (Holder, Needle, Gastroenterologic). FDA records list 49 510(k) clearances for Phx Technologies Corp., from to . As of , FDA records show no recalls naming K974327.

Clearance record

Decision date
Received
(52 days to decision)
Product code
FHQ Holder, Needle, Gastroenterologic
Regulation
21 CFR 876.4730
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Phx Technologies Corp. 1032 Shady Oaks Dr., # 100, Denton TX
510(k) summary
Summary
Third party review
No

Clearances, product code FHQ

Trailing 12 months

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

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