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510(k) K913267

R-GROUP INTL. ONE WALL PUNCTURE NEEDLE by R-Group Intl. — Product Code DRC

K913267 is an FDA 510(k) premarket notification submitted by R-Group Intl. for the device "R-GROUP INTL. ONE WALL PUNCTURE NEEDLE". The FDA issued a decision of Substantially Equivalent on June 5, 1992. The device falls under product code DRC (Trocar), a Class II device regulated under 21 CFR 870.1390. R-Group Intl. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1992
Date Received
July 23, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trocar
Device Class
Class II
Regulation Number
870.1390
Review Panel
CV
Submission Type

Other clearances by R-Group Intl.

  • K001233 — ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S (December 13, 2000)
  • K001599 — ACTI-FLEX IV ADMINISTRATION SET (September 18, 2000)
  • K993777 — DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES (May 25, 2000)
  • K952470 — ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. (November 28, 1995)
  • K954035 — ACTI-FLEX ARTERIAL EXTENSION SET (September 25, 1995)
  • K940319 — R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE (November 10, 1994)

Other clearances for product code DRC

  • K240246 — Accusafe Transseptal Guidewire (GTR31180, GTR31230) (July 26, 2024)
  • K241042 — SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) (May 17, 2024)
  • K221707 — SafeSept® Transseptal Guidewire (SS-140) (September 14, 2022)
  • K212625 — PathBuilder Transseptal Needle (March 23, 2022)
  • K210328 — SafeSept Blunt Needle (March 5, 2021)
  • K172950 — TSN Transseptal Needle (February 21, 2018)
  • K172934 — Needle Free Transseptal Cannula (February 16, 2018)
  • K172893 — SafeSept Needle Free Transseptal Guidewire (December 21, 2017)
  • K170671 — SafeSept Transseptal Guidewire (October 20, 2017)
  • K132943 — INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE (August 29, 2014)

FDA data resources