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510(k) K980069

VANISHPOINT SYRINGE by Retractable Technologies, Inc. — Product Code MEG

K980069 is an FDA 510(k) premarket notification submitted by Retractable Technologies, Inc. for the device "VANISHPOINT SYRINGE". The FDA issued a decision of Substantially Equivalent on February 12, 1998. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Retractable Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1998
Date Received
January 8, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Antistick
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Retractable Technologies, Inc.

  • K202325 — EasyPoint Blood Collection Plus (April 9, 2021)
  • K133635 — EASYPOINT NEEDLE (June 17, 2014)
  • K122355 — VANISHPOINT BLOOD COLLECTION SET (August 23, 2013)
  • K112512 — VANISHPOINT BLOOD COLLECTION SET (October 20, 2011)
  • K101708 — PATIENT SAFE LUER CAP (February 24, 2011)
  • K081420 — VANISHPOINT I.V. CATHETER (November 7, 2008)
  • K072654 — PATIENT SAFE SYRINGE (December 14, 2007)
  • K051355 — VANISHPOINT I.V. CATHETER (September 23, 2005)
  • K973301 — ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE (November 7, 1997)
  • K971763 — BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER (August 26, 1997)

Other clearances for product code MEG

  • K252098 — PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) (February 18, 2026)
  • K250847 — VaporShield (December 12, 2025)
  • K230287 — SaviSafe Safety Device (November 21, 2023)
  • K231165 — Shina Syringe; Shina Safety Syringe (October 27, 2023)
  • K231907 — Medline Safety Insulin and TB Syringes (October 18, 2023)
  • K223376 — Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject M (June 21, 2023)
  • K220114 — PowerPAK Syringe (January 25, 2023)
  • K221981 — SafeR Syringe and SafeR Sting (December 29, 2022)
  • K222452 — Disposable Automatically Retractable Safety Syringes (with detachable needle) (November 23, 2022)
  • K221247 — Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with N (November 1, 2022)

FDA data resources