Heavy Drainage Pack
FDA 510(k) K803116 · American Medical Disposable, Inc.
510(k) numberK803116
Submission
- Device name
- Heavy Drainage Pack
- Applicant
- American Medical Disposable, Inc.
Mchenry, IL, US - Received
- December 10, 1980
- Decision date
- January 28, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEC – Brush, Scrub, Operating-Room
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GEC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971473 | Ivalon Instrument Wipe, Ivalon Knife Cleaning BlockGEC · Traditional | M-Pact Worldwide Management Corp. | 07/07/1997SE |
| K960621 | Expandacell Instrument WipeGEC · Traditional | Shippert Medical Technologies Corp. | 04/01/1996SE |
| K900691 | Biodyne Instrument WipesGEC · Traditional | Bio-Dyne, Inc. | 03/08/1990SE |
| K896085 | Surgi-BrushGEC · Traditional | Sparta Surgical Corp. | 11/08/1989SE |
| K875033 | Sterile Scrubby Scrub BrushGEC · Traditional | Medsurg Industries, Inc. | 02/19/1988SESD |
| K875129 | Steri-ClensGEC · Traditional | Absorbent Cotton Co., Inc. | 02/18/1988SE |
| K872823 | Delta ScrubGEC · Traditional | Pacific Biosystems, Inc. | 01/07/1988SE |
| K874653 | Sterile Surgical Scrub BrushGEC · Traditional | Surgikos, Inc. | 12/30/1987SE |
| K874741 | Steri-Clens(Tm) Surgical Scrub SpongeGEC · Traditional | Absorbent Cotton Co., Inc. | 12/10/1987SE |
| K870258 | Bioscrub Surgical Scrub BrushGEC · Traditional | K. W. Griffen Co. | 02/24/1987SE |
More from K. W. Griffen Co.
| 510(k) | Device | Decision |
|---|---|---|
| K833735 | An Odor Absorbent BandageNAB · Traditional | 04/23/1984SE |
| K833734 | Neurological Sponge on Plastic Stick · Traditional | 04/23/1984SE |
| K833731 | Breathable Overwray Bandage Non-ElasKGX · Traditional | 01/27/1984SE |
| K833730 | Non Adherent Bandage/SheetFRO · Traditional | 01/27/1984SE |
| K833729 | Elastic Breathable Over-Wrap BandageNAD · Traditional | 12/30/1983SE |
| K833733 | Non - Adherent BandageFRO · Traditional | 12/27/1983SE |
| K833732 | Non Wetting Undercast PaddingITG · Traditional | 12/12/1983SE |
| K830202 | Cotton Balls, X-Ray Opaqued Strung & NonGDY · Traditional | 02/23/1983SE |
| K830201 | Polyester X-Ray Detectable Strung-SpongeGDY · Traditional | 02/23/1983SE |
| K803115 | Dressing Change for G TubeFRO · Traditional | 01/06/1981SE |
Questions and answers
When was Heavy Drainage Pack cleared by the FDA?
Heavy Drainage Pack (K803116) received a 510(k) decision of Substantially Equivalent on January 28, 1981, 49 days after the submission was received.
What is the product code of K803116?
The FDA product code is GEC – Brush, Scrub, Operating-Room, a Class I (low risk) device regulated under 21 CFR 878.4800.