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510(k) K942484

VERRES NEEDLE by Linvatec Corp. — Product Code FHO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1994
Date Received
May 25, 1994
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.

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  • K083281 — EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL (February 25, 2009)
  • K060198 — MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND (May 11, 2006)
  • K060270 — MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL (April 10, 2006)
  • K060260 — MICROPOWER HAND PIECE HIGH SPEED DRILL (April 10, 2006)
  • K050519 — ADVANCED TURBO DRIVE SYSTEM (May 17, 2005)
  • K050497 — BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET (March 25, 2005)

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)
  • 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)