# K964387: Point of Use II Sharps-a-Gator

- Pathway: 510(k) (Traditional)
- Applicant: Graphic Controls Corp.
- Decided: Mar 27, 1997 after 143 days
- Product code: MMK (Container, Sharps)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Point of Use Sharps-A-Gator: named in the summary without a submission number
- (no number) Sage In-Room and Sharpstar Disposal System: named in the summary without a submission number

## Most influential descendants
- K991612: Sterisharp 2.5-Gallon RSDC, Model #RSDC2.5G (1999), 4 descendants of its own
- K020664: Sterisharp 3-Gallon RSDC, Model RSDC3G (2002), 3 descendants of its own
- K083511: Enviro Sharp Solutions 3 (2009), 1 descendant of its own
- K990936: The Vault (1999), 1 descendant of its own
- K131087: Sharpstank Reusable Sharps Container (2013), 0 descendants of its own

## Indications for use
The Point of Use Il Sharps-A-Gator® will be used as a sharps container/disposal system. It can be used in any area requiring sharps collection prior to their final disposal. e.g. operating room, emergency room, patient room, pediatrics, doctor's office etc The Point Of Use Il Sharps-A-Gator® is for single use only and must be disposed of after its maximum capacity level is reached.

Source page: https://510kreport.com/device/K964387
Methodology: https://510kreport.com/methodology