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510(k) K851113

RANDALL KIDNEY STONE FORCEPS 817-144 PCS. FULL CUR by The Huxley Instrument Corp. — Product Code KOA

K851113 is an FDA 510(k) premarket notification submitted by The Huxley Instrument Corp. for the device "RANDALL KIDNEY STONE FORCEPS 817-144 PCS. FULL CUR". The FDA issued a decision of Substantially Equivalent on April 3, 1985. The device falls under product code KOA (Surgical Instruments, G-U, Manual (And Accessories)), a Class I device regulated under 21 CFR 876.4730. The Huxley Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1985
Date Received
March 19, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgical Instruments, G-U, Manual (And Accessories)
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type

Other clearances by The Huxley Instrument Corp.

  • K852721 — BOZEMAN UTERINE FORCEPS, STRAIGHT, 10+410 0R 420 (September 6, 1985)
  • K852993 — BONE RONGEURS (August 7, 1985)
  • K853016 — STILLE ANGULAR RONGEUR, 8-3/4 SS 410 (August 7, 1985)
  • K853015 — SELF-CENTERING BONE HOLDING FORCEPS, 10-1/4 SS420 (July 29, 1985)
  • K852716 — TAYLOR PERCUSSION HAMMER SS 410 OR 420 (July 26, 1985)
  • K852730 — CRILE FORCEPS, STRIAGHT, 6-1/4+SS 410 OR 420 (July 15, 1985)
  • K852713 — RUSSIAN TISSUE FORCEPS, 6 + SS 410 OR 420 (July 15, 1985)
  • K852734 — O.R. SCISSORS, STRAIGHT, 5-1/2+SHP/SHP SS (July 15, 1985)
  • K852728 — KELLY HEMOSTATIC FORCEPS, STRAIGHT 5-1/2+SS (July 15, 1985)
  • K852719 — MAYO HEGAR NEEDLE HOLDER, G+SS 410 OR 420 (July 15, 1985)

Other clearances for product code KOA

  • K182664 — FiXcision (December 7, 2018)
  • K950267 — URETHRAL SUTURE GUIDE (January 31, 1995)
  • K932465 — LI VASECTOMY (March 2, 1994)
  • K921546 — VASOVASOSTOMY SET (July 2, 1993)
  • K931181 — VESITEC SUTURE PASSER (May 12, 1993)
  • K921304 — DDV LIGATOR (October 5, 1992)
  • K922971 — NO-SCALPEL VASCETOMY INSTRUMENTS (September 23, 1992)
  • K921228 — BENDEREV PROTECT-A-PASS NEEDLE (September 14, 1992)
  • K922192 — VAS DILATOR (August 7, 1992)
  • K896058 — GRASPING FORCEPS (December 28, 1989)

FDA data resources