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510(k) K851162

AL ASKARI PERCUTANEOUS ACCESS NEEDLE HOLDER by Van-Tec, Inc. — Product Code KOA

K851162 is an FDA 510(k) premarket notification submitted by Van-Tec, Inc. for the device "AL ASKARI PERCUTANEOUS ACCESS NEEDLE HOLDER". The FDA issued a decision of Substantially Equivalent on April 15, 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. Van-Tec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1985
Date Received
March 22, 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 Van-Tec, Inc.

  • K880096 — VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUP (March 2, 1988)
  • K880098 — VAN-TEC AUTO BIOPSY NEEDLE (March 2, 1988)
  • K880099 — VAN-TEC BLADDER EVACUATOR (March 2, 1988)
  • K880095 — BERGER PROSTATE CULTURE CYTOLOGY BRUSH (March 2, 1988)
  • K880094 — VAN-TEC ENDOPYELOTOMY KNIFE (February 29, 1988)
  • K874112 — VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER (February 11, 1988)
  • K871777 — VAN-TEC REUSABLE HELICAL STONE BASKET (June 17, 1987)
  • K871779 — HELICAL STONE BASKET (DISPOSABLE) (June 17, 1987)
  • K870679 — VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE (March 30, 1987)
  • K870557 — VAN-TEC PUMPING SYSTEM (March 30, 1987)

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