Ultracell Orthopedic Sponges
FDA 510(k) K950372 · Ultracell Medical Technologies, Inc.
510(k) numberK950372
Submission
- Device name
- Ultracell Orthopedic Sponges
- Applicant
- Ultracell Medical Technologies, Inc.
Old Mystic, CT, US - Received
- January 31, 1995
- Decision date
- April 17, 1995
- 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 |
|---|---|---|
| K012196 | Ultracell Absorbent StickHOZ · Traditional | 08/24/2001SE |
| K972634 | Ultracell Suction SpongeGDY · Traditional | 12/17/1997SE |
| K972633 | Ultracell Suction SpongeHOZ · Traditional | 12/17/1997SE |
| K973083 | Ultracell Neuro SpongesHBA · Traditional | 12/09/1997SE |
| K973558 | Visual Endoscopic Non-Alcohol Ultracell Sponge (Venus)FEB · Traditional | 11/24/1997SE |
| K973085 | Ultracell Packing with SleeveEMX · Traditional | 11/18/1997SE |
| K972635 | Ultracell Suction SpongeGBX · Traditional | 10/01/1997SE |
| K970328 | Ultracell Neuro SpongesHBA · Traditional | 04/21/1997SE |
| K950647 | Ultracell Neuro SpongesHBA · Traditional | 08/15/1995SE |
| K950373 | Ultracell Orthopedic SpongesGDY · Traditional | 04/17/1995SE |
Questions and answers
When was Ultracell Orthopedic Sponges cleared by the FDA?
Ultracell Orthopedic Sponges (K950372) received a 510(k) decision of Substantially Equivalent on April 17, 1995, 76 days after the submission was received.
What is the product code of K950372?
The FDA product code is GDY – Gauze/Sponge, Internal, X-Ray Detectable, a Class I (low risk) device regulated under 21 CFR 878.4450.