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510(k) K121370

VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE by Vectec — Product Code FHO

K121370 is an FDA 510(k) premarket notification submitted by Vectec for the device "VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE". The FDA issued a decision of Substantially Equivalent on August 2, 2013. The device falls under product code FHO (Pneumoperitoneum Needle), a Class II device regulated under 21 CFR 876.1500. Vectec has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2013
Date Received
May 7, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pneumoperitoneum Needle
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

For establishment of a pneumoperitoneum in abdomen.

Other clearances by Vectec

  • K103707 — VECTEC DISPOSABLE MONOPOLAR CONNECTOR CABLE (February 4, 2011)
  • K071976 — VECTEC DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES (September 6, 2007)

Other clearances for product code FHO

  • K172120 — Veress Needle (September 14, 2017)
  • K010779 — MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT (April 10, 2001)
  • K970788 — PNEUMO-MATIC INSUFFLATION NEEDLE (March 27, 1997)
  • K960574 — ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC C (August 5, 1996)
  • K951894 — ACCESS EXPANSION SYSTEM (June 15, 1995)
  • K943624 — ELMED PNEUMOPERITONEUM NEEDLES (August 10, 1994)
  • K942484 — VERRES NEEDLE (June 24, 1994)
  • K930474 — NEEDLE, PNEUMOPERITONEUM, SPRING LOADED (July 23, 1993)
  • K915725 — CLARUS MODELS 1230 AND 1231 LAPARO-NEEDLE (November 16, 1992)
  • K914426 — ENTREE NEEDLE (November 27, 1991)

FDA data resources