Kevorkian-Younge Biopsy Curette #90-6611

• • Ongoing Z-0943-2025 FDA Class II ·initiated 3 Dec 2024 ·via K802458, on the same 510(k)

  Reports of various packaging issues that may result in a breach of the sterile barrier.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K802458 ↗

FDA Product Code

HFB

Device Class

Class I

Regulation

21 CFR Part 884.4530

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Kogan Endospeculum 9-1/2

  Class I

  FDA 510(k) K842111 Active Cleared 19 Jun 1984

• Rudd-Clinic Hemorrhoidal Forceps

  Class I

  FDA 510(k) K800441 Active Cleared 8 Apr 1980

• Miniclamps, Stabiliz., Fallopian Tube Open recall

  Class II

  FDA 510(k) K772229 Active Cleared 3 Jan 1978

• Gusberg Hysterectomy Clamp

  Class I

  FDA 510(k) K771344 Active Cleared 27 Jul 1977

• Hemorrhoidal Ligator

  Class I

  FDA 510(k) K790577 Active Cleared 23 Apr 1979

• Leff Stethoscope for Fetal Heart

  Class I

  FDA 510(k) K761338 Active Cleared 12 Jan 1977

See all devices from J. Sklar Mfg. Co., Inc. →