Htr Polymer, Htr-Mx

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K904111 ↗

FDA Product Code

KKY

Device Class

Class II

Regulation

21 CFR Part 878.3500

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Modified Auto Suture Endoscopic Gia Surg. Stapler*

  Class II

  FDA 510(k) K900129 Active Cleared 27 Feb 1990

• Auto Suture(R) Endoscopic Gia(Tm) Surgical Stapler

  Class II

  FDA 510(k) K892233 Active Cleared 28 Apr 1989

• Caprosyn Absorbable Suture

  Class II

  FDA 510(k) K032586 Active Cleared 17 Nov 2003

• Auto Suture Disposable Gia Surg. Stapler

  Class I

  FDA 510(k) K801590 Active Cleared 4 Aug 1980

• Endoscope Suture & Carrier

  Class II

  FDA 510(k) K912973 Active Cleared 27 Sep 1991

• Modified Surgiport Disposable Trocar and Sleeve

  Class I

  FDA 510(k) K903419 Active Cleared 9 Aug 1990

See all devices from United States Surgical, A Division of Tyco Healthc →

• What is HTR POLYMER used for?

  HTR POLYMER is designed for use in maxillofacial reconstruction procedures, serving as an implantable material for reconstructive applications in general and plastic surgery.

• Is HTR POLYMER single-use or reusable?

  HTR POLYMER is supplied as a single-use material, meaning it should be used only once for each patient and then discarded according to medical waste disposal protocols.

• What are the regulatory classifications for HTR POLYMER?

  HTR POLYMER is regulated under FDA 510(k) clearance with product code KKY, classified as a Class II device, and received FDA clearance in 1990.

• What is HTR POLYMER composed of?

  HTR POLYMER is composed of Polytetrafluoroethylene Vitreous Carbon, a material specifically designed for implantable use in reconstructive surgical procedures.