Home / 510(k) Clearances / K930474

510(k) K930474

NEEDLE, PNEUMOPERITONEUM, SPRING LOADED by Ranfac, Corp. — Product Code FHO

K930474 is an FDA 510(k) premarket notification submitted by Ranfac, Corp. for the device "NEEDLE, PNEUMOPERITONEUM, SPRING LOADED". The FDA issued a decision of Substantially Equivalent on July 23, 1993. The device falls under product code FHO (Pneumoperitoneum Needle), a Class II device regulated under 21 CFR 876.1500. Ranfac, Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1993
Date Received
January 28, 1993
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 Ranfac, Corp.

  • K162932 — Ranfac Fat Aspiration Cannula (January 19, 2017)
  • K150156 — Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspirat (October 19, 2015)
  • K150563 — Marrow Cellution Bone Marrow Aspiration Needle (May 22, 2015)
  • K140991 — RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE (September 11, 2014)
  • K131157 — RANFAC BONE MARROW ASPIRATION NEEDLE (October 22, 2013)
  • K031344 — RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE (May 23, 2003)
  • K012224 — SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW (August 22, 2001)
  • K961922 — RDP-2 (August 9, 1996)
  • K951090 — INTRODUCER (July 11, 1995)
  • K864139 — RANFAC CUT BIOPSY NEEDLE (November 5, 1986)

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)
  • K915725 — CLARUS MODELS 1230 AND 1231 LAPARO-NEEDLE (November 16, 1992)
  • K914426 — ENTREE NEEDLE (November 27, 1991)

FDA data resources