Wiltek Hot Biopsy Forceps

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

510(k) Number

K990231 ↗

FDA Product Code

KGE

Device Class

Class II

Regulation

21 CFR Part 876.4300

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Wiltek Electrocautery Adaptor

  Class II

  FDA 510(k) K914131 Active Cleared 25 Sep 1991

• Wiltek Biopsy Forceps

  Class II

  FDA 510(k) K930419 Active Cleared 1 Jun 1993

• Wiltek E.R.C.P. Catheter

  Class II

  FDA 510(k) K894867 Active Cleared 21 Dec 1989

• Wiltek Papillotome

  Class II

  FDA 510(k) K894861 Active Cleared 21 Dec 1989

• Wiltek Cytology Brush

  Class II

  FDA 510(k) K894863 Active Cleared 21 Dec 1989

• Wiltek Balloon Stone Extractor

  Class II

  FDA 510(k) K894865 Active Cleared 21 Dec 1989

See all devices from Wiltek Medical, Inc. →

• What is the Wiltek Hot Biopsy Forceps used for?

  The Wiltek Hot Biopsy Forceps is a forceps, biopsy, electric device used for transendoscopic biopsy of the GI tract, as stated in the device description. It is intended for use in gastroenterology and urology settings, based on the medical specialty description and advisory committee classification provided in the data.

• How is the Wiltek Hot Biopsy Forceps supplied and authorized?

  The device is supplied by Wiltek Medical, Inc. and is authorized under FDA 510(k) clearance K990231, as explicitly stated in the device data. It was cleared via the traditional 510(k) pathway and is classified as a Class II device.

• Is the Wiltek Hot Biopsy Forceps a single-use or reusable device?

  The device data does not specify whether the Wiltek Hot Biopsy Forceps is single-use or reusable. No information about sterility, reprocessing, or reuse instructions is provided in the specifications or description fields, so this detail cannot be inferred from the given data.

• What regulatory pathway was used for the Wiltek Hot Biopsy Forceps?

  The device was cleared via the traditional 510(k) pathway, as indicated by the clearance_type field stating 'Traditional' and the decision_description noting it is 'Substantially Equivalent'. This reflects the regulatory route under which FDA authorization was granted.

• What is the classification and product code for the Wiltek Hot Biopsy Forceps?

  The device is classified as Class II, as shown in the openfda field where device_class=2, and its product code is KGE, as listed in the product_code field. These are formal regulatory identifiers from the device's authorization record.