Conphar Nelaton Catheter-Sterile

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K791264 ↗

FDA Product Code

KOD

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Mayo Scissor Curyed 5 1/2

  Class I

  FDA 510(k) K821276 Active Cleared 28 May 1982

• Crile, Curved Forceps 5 1/2

  Class I

  FDA 510(k) K821281 Active Cleared 27 May 1982

• Mayo-Hegar Needle Holder

  Class I

  FDA 510(k) K821289 Active Cleared 3 Jun 1982

• Backhaus Clamp, 5 1/4

  Class I

  FDA 510(k) K821293 Active Cleared 28 May 1982

• Kelly Forceps Curved 5 1/2

  Class I

  FDA 510(k) K821277 Active Cleared 27 May 1982

• Crile Forceps Straight 5 1/2

  Class I

  FDA 510(k) K821287 Active Cleared 27 May 1982

See all devices from Conphar, Inc. →

• What is the primary purpose of the Conphar Nelaton Catheter-Sterile?

  This device is a urological catheter specifically designed to facilitate the drainage of urine from the bladder.

• Is the Conphar Nelaton Catheter-Sterile supplied in a sterile condition?

  Yes, the device is supplied in a sterile condition to ensure it meets the necessary requirements for clinical use upon opening.

• What is the regulatory status of this catheter?

  The Conphar Nelaton Catheter-Sterile is regulated under FDA 510(k) clearance K791264, which confirms its status as a cleared medical device.