Porges Hot Biopsy Forceps

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

510(k) Number

K896537 ↗

FDA Product Code

KGE

Device Class

Class II

Regulation

21 CFR Part 876.4300

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Porges Endoscopic Dormia Extractors, Dormiatriptor

  Class II

  FDA 510(k) K896506 Active Cleared 26 Jan 1990

• Porges Nasobiliary Drain

  Class II

  FDA 510(k) K896376 Active Cleared 22 Jan 1990

• Porges Sclerotherapy Needles

  Class II

  FDA 510(k) K896424 Active Cleared 26 Jan 1990

• Porges ERCP Catheters

  Class II

  FDA 510(k) K896503 Active Cleared 30 Jan 1990

• Biliary Endoprosthesis for Internal Drainage Set

  Class II

  FDA 510(k) K892383 Active Cleared 4 May 1989

• Modified Pediatric Silicone Foley Catheters

  Class II

  FDA 510(k) K900031 Active Cleared 6 Mar 1990

See all devices from Porges Corp. →

• What is the Porges Hot Biopsy Forceps used for?

  The Porges Hot Biopsy Forceps is an endoscopic electrosurgical unit accessory used to perform electrosurgical procedures through an endoscope, specifically intended for use in gastroenterology and urology settings as indicated by its classification under product code KGE and regulation number 876.4300.

• How was the Porges Hot Biopsy Forceps cleared for market?

  The device was cleared via the FDA 510(k) process under submission K896537 on November 30, 1989, with a substantially equivalent decision, meaning it was found to be substantially equivalent to a legally marketed predicate device.

• What regulatory classification does the Porges Hot Biopsy Forceps have?

  The Porges Hot Biopsy Forceps is classified as a Class II medical device under FDA regulations, which subjects it to special controls in addition to general controls to ensure its safety and effectiveness for its intended use.