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510(k) K904849

ORIGINEEDLE(TM) by Origin Medsystems, Inc. — Product Code FHO

K904849 is an FDA 510(k) premarket notification submitted by Origin Medsystems, Inc. for the device "ORIGINEEDLE(TM)". The FDA issued a decision of Substantially Equivalent on March 29, 1991. The device falls under product code FHO (Pneumoperitoneum Needle), a Class II device regulated under 21 CFR 876.1500. Origin Medsystems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1991
Date Received
October 26, 1990
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 Origin Medsystems, Inc.

  • K992353 — BLUNT TIP TROCAR PORT (July 30, 1999)
  • K981700 — VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEM (May 29, 1998)
  • K972685 — ORIGIN LIGATOR DEVICE (October 1, 1997)
  • K970611 — ORIGIN CARDIAC STABLIZER OCCLUDER (August 19, 1997)
  • K965121 — CANNULA (March 20, 1997)
  • K964171 — VASOVIEW BALLOON DISSECTION SYSTEM (February 14, 1997)
  • K962104 — AIRLIFT BALLOON RETRACTON SYSTEM (September 11, 1996)
  • K962005 — EXTRAHAND BALLOON RETRACTOR (August 12, 1996)
  • K960936 — RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES] (July 24, 1996)
  • K960637 — 5MM ENDOSCOPE (June 14, 1996)

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)
  • 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)

FDA data resources