Home / 510(k) Clearances / K964387

510(k) K964387

POINT OF USE II SHARPS-A-GATOR by Graphic Controls Corp. — Product Code MMK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1997
Date Received
November 4, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Sharps
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Graphic Controls Corp.

  • K981964 — MEDI-TRACE 4103 NEONATAL ELECTRODE (November 13, 1998)
  • K983287 — MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE (November 5, 1998)
  • K974730 — SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUP (July 14, 1998)
  • K980857 — MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE (May 12, 1998)
  • K972970 — MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE (August 27, 1997)
  • K964279 — SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) (January 22, 1997)
  • K963151 — MEDI-TRACE 5700 RESTING ECG ELECTRODE (November 19, 1996)
  • K963038 — MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE (November 15, 1996)
  • K960968 — MEDI-TRACE 200, MEDI-TRACE 200-30 (October 28, 1996)
  • K955882 — MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBR (October 24, 1996)

Other clearances for product code MMK

  • K253222 — Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) (December 22, 2025)
  • K251874 — PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) (October 14, 2025)
  • K252637 — Community Containers (Flap and Daisy) (October 14, 2025)
  • K231484 — PureWay 1.4 Quart Sharps Collector (September 14, 2023)
  • K222906 — Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421 (June 16, 2023)
  • K222905 — Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (June 1, 2023)
  • K213274 — Qlicksmart BladeFlask UNIVERSAL (June 22, 2022)
  • K211890 — Promisemed Sharps container (November 17, 2021)
  • K211464 — Nitta M&T Safety Box (September 14, 2021)
  • K203305 — Tiger Reusable Sharps Container (August 6, 2021)