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510(k) K970788

PNEUMO-MATIC INSUFFLATION NEEDLE by Apple Medical Corp. — Product Code FHO

K970788 is an FDA 510(k) premarket notification submitted by Apple Medical Corp. for the device "PNEUMO-MATIC INSUFFLATION NEEDLE". The FDA issued a decision of Substantially Equivalent on March 27, 1997. The device falls under product code FHO (Pneumoperitoneum Needle), a Class II device regulated under 21 CFR 876.1500. Apple Medical Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1997
Date Received
March 4, 1997
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 Apple Medical Corp.

  • K061651 — FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 (October 20, 2006)
  • K050256 — APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR (April 26, 2005)
  • K041131 — APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR (May 13, 2004)
  • K014005 — APPLE MEDICAL MOBIUS ELASTIC RETRACTOR (February 15, 2002)
  • K000026 — APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER (March 31, 2000)
  • K961460 — LWEET CONE BIOPSY INSTRUMENT (November 19, 1996)
  • K952841 — THE ASSISTANT (August 18, 1995)
  • K941506 — URETERAL ILLUMINATOR (October 5, 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)
  • 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