Retractor

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K954508 ↗

FDA Product Code

HRX

Device Class

Class II

Regulation

21 CFR Part 888.1100

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Hydro-Probe

  Class II

  FDA 510(k) K934157 Active Cleared 26 Jan 1994

• Sterile, Disposable Endoscopic Trumpet Valve

  Class II

  FDA 510(k) K934098 Active Cleared 16 Dec 1993

• Watts Rake with Leur Lock Port

  Class II

  FDA 510(k) K934153 Active Cleared 18 Mar 1994

• 5, 6, 7, 9, 10, 11&12mm Blunt-Tipped Trocar Obturators

  Class II

  FDA 510(k) K934511 Active Cleared 17 Feb 1994

• Phx Technologies Corp., Bowel Grasper Device

  Class II

  FDA 510(k) K934021 Active Cleared 17 Dec 1993

• Phx Technologies Corp. Bowel Grasper Device

  Class II

  FDA 510(k) K934026 Active Cleared 17 Dec 1993

See all devices from Phx Technologies Corp. →

• What is the primary function of the Phx Technologies Retractor?

  This surgical instrument is designed to hold back the edges of a surgical incision or wound. By maintaining this retraction, it provides surgeons with improved access to underlying tissues and structures during orthopedic operations.

• In which medical specialty is this retractor used?

  The device is categorized for use within the orthopedic medical specialty. It is specifically intended to assist clinicians in managing surgical sites during orthopedic procedures.

• What is the regulatory status of this device?

  The Phx Technologies Retractor is identified under FDA 510(k) clearance number K954508. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.