Gauze Sponges
FDA 510(k) K944879 · Clinical Resources, Inc.
510(k) numberK944879
Submission
- Device name
- Gauze Sponges
- Applicant
- Clinical Resources, Inc.
Elgin, IL, US - Received
- October 3, 1994
- Decision date
- December 23, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K941470 | Tracheostomy Care KitBTO · Traditional | 02/14/1995SESK |
| K944882 | Irrigation TrayEYN · Traditional | 01/12/1995SE |
| K944881 | Skin Scrub TrayFRG · Traditional | 12/27/1994SEKD |
| K945021 | Fluff Gauze SpongeEFQ · Traditional | 12/23/1994SE |
| K945020 | Fluff Gauze SpongeEFQ · Traditional | 12/23/1994SE |
| K945019 | Fluff Gauxze RollEFQ · Traditional | 12/23/1994SE |
| K944880 | Bodily Fluid Disposal KitFXX · Traditional | 12/15/1994SE |
| K941471 | Central Line Dressing Change TrayFRG · Traditional | 05/12/1994SE |
| K941469 | IV Start KitLRS · Traditional | 05/12/1994SE |
| K941468 | Debridement Tray, Incision and Drainage TrayFRG · Traditional | 05/12/1994SE |
Questions and answers
When was Gauze Sponges cleared by the FDA?
Gauze Sponges (K944879) received a 510(k) decision of Substantially Equivalent on December 23, 1994, 81 days after the submission was received.
What is the product code of K944879?
The FDA product code is GDY – Gauze/Sponge, Internal, X-Ray Detectable, a Class I (low risk) device regulated under 21 CFR 878.4450.