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510(k) K951894

ACCESS EXPANSION SYSTEM by Micro-Medical Devices, Inc. — Product Code FHO

K951894 is an FDA 510(k) premarket notification submitted by Micro-Medical Devices, Inc. for the device "ACCESS EXPANSION SYSTEM". The FDA issued a decision of Substantially Equivalent (kit) on June 15, 1995. The device falls under product code FHO (Pneumoperitoneum Needle), a Class II device regulated under 21 CFR 876.1500. Micro-Medical Devices, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
June 15, 1995
Date Received
April 24, 1995
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 Micro-Medical Devices, Inc.

  • K003695 — MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5 (February 14, 2001)
  • K983882 — MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL (March 15, 1999)
  • K963675 — THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE (January 27, 1997)
  • K951482 — ENDOSCOPES, FIBER OPTIC LAPAROSCOPES, (STERILIZABLE) (September 14, 1995)
  • K945656 — THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE (March 28, 1995)
  • K940141 — LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH (May 19, 1994)
  • K936213 — ARTHROSCOPES AND ACCESSORIES (May 18, 1994)

Other clearances for product code FHO

  • K172120 — Veress Needle (September 14, 2017)
  • K121370 — VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE (August 2, 2013)
  • 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)
  • 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