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510(k) K153472

Quiver Laparoscopic Extendable by Itl Corporation Pty, Ltd. — Product Code HAM

K153472 is an FDA 510(k) premarket notification submitted by Itl Corporation Pty, Ltd. for the device "Quiver Laparoscopic Extendable". The FDA issued a decision of Substantially Equivalent on June 23, 2016. The device falls under product code HAM (Apparatus, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Itl Corporation Pty, Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2016
Date Received
December 2, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Electrosurgical
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Other clearances by Itl Corporation Pty, Ltd.

  • K021941 — SAMPLOK LUER KIT (July 2, 2002)
  • K021017 — LEESPEC DISPOSABLE VAGINAL SPECULUM (June 19, 2002)
  • K000777 — SAMPLOK (April 11, 2000)
  • K991404 — PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP) (May 14, 1999)

Other clearances for product code HAM

  • K000079 — NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M (February 4, 2000)
  • K993306 — NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4 (November 3, 1999)
  • K945861 — BERGEN 710 ESU (March 1, 1995)
  • K913300 — LAPAROSTAT(TM) (April 2, 1992)
  • K920100 — GSU HANDPIECE ADAPTER (February 3, 1992)
  • K911353 — EMC MODEL NO. STATOME 900 (June 24, 1991)
  • K901248 — ABC HANDPIECE ADAPTER (April 3, 1990)
  • K881334 — LIGHT COAGULATOR LC 250 (November 16, 1989)
  • K894762 — B100 DISPOSABLE HANDPIECE (September 15, 1989)
  • K895337 — ELECTROSURGICAL COAGULATION SUCTION TUBE (September 15, 1989)

FDA data resources