510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934510Substantially Equivalent

5,6,7,9,10,11,12Mm Blunt-Tip Trocar Obtur/thread

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

K934510 is the FDA 510(k) clearance record for 5,6,7,9,10,11,12MM BLUNT-TIP TROCAR OBTUR/THREAD, a class II device, cleared for Phx Technologies Corp. on under FDA product code GCL (Esophagoscope, General & Plastic Surgery). FDA's definition for product code GCL reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 49 510(k) clearances for Phx Technologies Corp., from to . As of , FDA records show no recalls naming K934510.

Clearance record

Decision date
Received
(156 days to decision)
Product code
GCL Esophagoscope, General & Plastic Surgery
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Phx Technologies Corp. Post Office Box 1059, Lewisville TX
510(k) summary
Statement
Third party review
No

Clearances, product code GCL

Trailing 12 months

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

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