Cherry Dissector
FDA 510(k) K953062 · Medical Perspectives Corp.
510(k) numberK953062
Submission
- Device name
- Cherry Dissector
- Applicant
- Medical Perspectives Corp.
Norwalk, CT, US - Received
- June 30, 1995
- Decision date
- September 14, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
|---|---|---|
| K953088 | Triangular SpongesGDY · Traditional | 09/14/1995SE |
| K953087 | Cherry Pit DissectorGDY · Traditional | 09/14/1995SE |
| K953060 | Rosebud DissectorGDY · Traditional | 09/14/1995SE |
| K953059 | Kittner DissectorGDY · Traditional | 09/14/1995SE |
| K953058 | Round Stick Sponges, Flat Stick SpongesGDY · Traditional | 09/14/1995SE |
| K953057 | Cylindrical SpongeGDY · Traditional | 09/14/1995SE |
Questions and answers
When was Cherry Dissector cleared by the FDA?
Cherry Dissector (K953062) received a 510(k) decision of Substantially Equivalent on September 14, 1995, 76 days after the submission was received.
What is the product code of K953062?
The FDA product code is GDY – Gauze/Sponge, Internal, X-Ray Detectable, a Class I (low risk) device regulated under 21 CFR 878.4450.