CPR Lap Sponges
FDA 510(k) K960236 · Custom Pack Reliability
510(k) numberK960236
Submission
- Device name
- CPR Lap Sponges
- Applicant
- Custom Pack Reliability
Orlando, FL, US - Received
- January 16, 1996
- Decision date
- March 28, 1996
- 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 |
| 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 |
| K953058 | Round Stick Sponges, Flat Stick SpongesGDY · Traditional | Medical Perspectives Corp. | 09/14/1995SE |
More from Medical Perspectives Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K960205 | CPR Tracheotomy Care TrayBTO · Traditional | 08/27/1996SE |
| K960243 | CPR C-Section Delivery PackMLS · Traditional | 05/23/1996SE |
| K960239 | CPR D & C TrayHHK · Traditional | 05/23/1996SE |
| K960216 | CPR Suction Catheter KitJOL · Traditional | 04/15/1996SE |
| K960213 | CPR Total Hip PackFRG · Traditional | 04/12/1996SE |
| K960211 | CPR Total Knee PackFRG · Traditional | 04/12/1996SE |
| K960210 | CPR Ortho Hand PackFRG · Traditional | 04/12/1996SE |
| K960206 | CPR Dressing Change TrayFRG · Traditional | 04/12/1996SE |
| K960209 | CPR Heart PackGAW · Traditional | 04/04/1996SE |
| K960215 | CPR Urethral Catheter TrayFCM · Traditional | 04/01/1996SE |
Questions and answers
When was CPR Lap Sponges cleared by the FDA?
CPR Lap Sponges (K960236) received a 510(k) decision of Substantially Equivalent on March 28, 1996, 72 days after the submission was received.
What is the product code of K960236?
The FDA product code is GDY – Gauze/Sponge, Internal, X-Ray Detectable, a Class I (low risk) device regulated under 21 CFR 878.4450.