Polyester X-Ray Detectable Strung-Sponge
FDA 510(k) K830201 · American Medical Disposable, Inc.
510(k) numberK830201
Submission
- Device name
- Polyester X-Ray Detectable Strung-Sponge
- Applicant
- American Medical Disposable, Inc.
Mchenry, IL, US - Received
- January 20, 1983
- Decision date
- February 23, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GDY – Gauze/Sponge, Internal, X-Ray Detectable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4450
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GDY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972634 | Ultracell Suction SpongeGDY · Traditional | Ultracell Medical Technologies, Inc. | 12/17/1997SE |
| K960236 | CPR Lap SpongesGDY · Traditional | Custom Pack Reliability | 03/28/1996SE |
| K955599 | Stryker Femoral Canal Sponge & Acetabulum SpongeGDY · Traditional | Stryker Corp. | 02/22/1996SE |
| K955322 | Protec X-Ray Detectable Gauze SpongeGDY · Traditional | Derivados DE Gasa, S.A. DE C.V. | 12/19/1995SE |
| K953830 | KensorbGDY · Traditional | Kentron Health Care, Inc. | 10/03/1995SE |
| K953088 | Triangular SpongesGDY · Traditional | Medical Perspectives Corp. | 09/14/1995SE |
| K953087 | Cherry Pit DissectorGDY · Traditional | Medical Perspectives Corp. | 09/14/1995SE |
| K953062 | Cherry DissectorGDY · Traditional | Medical Perspectives Corp. | 09/14/1995SE |
| K953060 | Rosebud DissectorGDY · Traditional | Medical Perspectives Corp. | 09/14/1995SE |
| K953059 | Kittner DissectorGDY · Traditional | Medical Perspectives Corp. | 09/14/1995SE |
More from Medical Perspectives Corp.
| 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 |
| K803116 | Heavy Drainage PackGEC · Traditional | 01/28/1981SE |
| K803115 | Dressing Change for G TubeFRO · Traditional | 01/06/1981SE |
Questions and answers
When was Polyester X-Ray Detectable Strung-Sponge cleared by the FDA?
Polyester X-Ray Detectable Strung-Sponge (K830201) received a 510(k) decision of Substantially Equivalent on February 23, 1983, 34 days after the submission was received.
What is the product code of K830201?
The FDA product code is GDY – Gauze/Sponge, Internal, X-Ray Detectable, a Class I (low risk) device regulated under 21 CFR 878.4450.