Point of Use II Sharps-A-Gator
FDA 510(k) K964387 · Graphic Controls Corp.
510(k) numberK964387
Submission
- Device name
- Point of Use II Sharps-A-Gator
- Applicant
- Graphic Controls Corp.
Chatsworth, CA, US - Received
- November 4, 1996
- Decision date
- March 27, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MMK – Container, Sharps
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
Other 510(k)s with product code MMK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260845 | Huahong Sharps Container (HHR-I, HHR-II)MMK · Traditional | Tianjin Huahong Technology Co., Ltd. | 08/05/2026SE |
| K253773 | Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong…MMK · Traditional | Taizhou Huangyan Guanhong Plastic Steel Products… | 05/22/2026SE |
| K253222 | Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)MMK · Traditional | Zhejiang Gongdong Medical Technology Co., Ltd. | 12/22/2025SE |
| K252637 | Community Containers (Flap and Daisy)MMK · Traditional | Keter Canada, Inc. | 10/14/2025SE |
| K251874 | PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)MMK · Traditional | Pureway Compliance, Inc. | 10/14/2025SE |
| K231484 | PureWay 1.4 Quart Sharps CollectorMMK · Traditional | Pureway Compliance, Inc. | 09/14/2023SE |
| K222906 | Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421MMK · Traditional | Ningbo Maxcon Medical Technology Co., Ltd. | 06/16/2023SE |
| K222905 | Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT…MMK · Traditional | Ningbo Maxcon Medical Technology Co., Ltd. | 06/01/2023SE |
| K213274 | Qlicksmart BladeFlask UNIVERSALMMK · Abbreviated | Qlicksmart Pty , Ltd. | 06/22/2022SE |
| K211890 | Promisemed Sharps containerMMK · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 11/17/2021SE |
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| K972970 | Medi-Trace 1510M Combination Defibrillation, Monitoring and Pacing ElectrodeMKJ · Traditional | 08/27/1997SE |
| K964279 | Softrans Intrauterine Pressure Catheter System (Iup 4000 Softrans Iupc)KXO · Traditional | 01/22/1997SE |
| K963151 | Medi-Trace 5700 Resting ECG ElectrodeDRX · Traditional | 11/19/1996SE |
| K963038 | Medi-Trace 3600 Series of ECG Monitoring ElectrodeDRX · Traditional | 11/15/1996SE |
| K960968 | Medi-Trace 200, Medi-Trace 200-30DRX · Traditional | 10/28/1996SE |
| K955923 | Medi-Trace Combination Defibrillation & ECG Electrode for LaerdalMKJ · Traditional | 10/24/1996SE |
Questions and answers
When was Point of Use II Sharps-A-Gator cleared by the FDA?
Point of Use II Sharps-A-Gator (K964387) received a 510(k) decision of Substantially Equivalent on March 27, 1997, 143 days after the submission was received.
What is the product code of K964387?
The FDA product code is MMK – Container, Sharps, a Class II (moderate risk) device regulated under 21 CFR 880.5570.