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510(k) K010779

MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT by Gibbons Surgical Corp. — Product Code FHO

K010779 is an FDA 510(k) premarket notification submitted by Gibbons Surgical Corp. for the device "MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT". The FDA issued a decision of Substantially Equivalent on April 10, 2001. The device falls under product code FHO (Pneumoperitoneum Needle), a Class II device regulated under 21 CFR 876.1500. Gibbons Surgical Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2001
Date Received
March 15, 2001
Clearance Type
Special
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 Gibbons Surgical Corp.

  • K012198 — GIBBONS STERILE TROCAR KITS (August 9, 2001)

Other clearances for product code FHO

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