Ultracell Suction Sponge
FDA 510(k) K972635 · Ultracell Medical Technologies, Inc.
510(k) numberK972635
Submission
- Device name
- Ultracell Suction Sponge
- Applicant
- Ultracell Medical Technologies, Inc.
North Stonington, CT, US - Received
- July 14, 1997
- Decision date
- October 1, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GBX – Catheter, Irrigation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
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| K043515 | GraftsaverGBX · Traditional | Vescare, Inc. | 03/31/2005SE |
| K013417 | Misonix Irrigation System Moedl BC20PGBX · Traditional | Misonix, Inc. | 01/10/2002SE |
| K000704 | DMC Saphenous Vein Distention System (SVDS)GBX · Traditional | Dmc Medical, Ltd. | 05/19/2000SE |
| K974233 | Lysonix Irrigation SystemGBX · Traditional | Lysonix, Inc. | 02/03/1998SE |
| K973703 | Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct Wound DrainGBX · Traditional | Allegiance Healthcare Corp. | 12/04/1997SE |
| K965146 | Flat Closed Wound Drain with TrocarGBX · Traditional | Axiom Medical, Inc. | 03/10/1997SE |
| K961295 | Sapphire Line Flat Drain/Kit with Spi-Argent II W/Or W/Out TrocarGBX · Traditional | Sil-Med Corp. | 06/26/1996SE |
More from Sil-Med 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 |
| K970328 | Ultracell Neuro SpongesHBA · Traditional | 04/21/1997SE |
| K950647 | Ultracell Neuro SpongesHBA · Traditional | 08/15/1995SE |
| K950373 | Ultracell Orthopedic SpongesGDY · Traditional | 04/17/1995SE |
| K950372 | Ultracell Orthopedic SpongesGDY · Traditional | 04/17/1995SE |
Questions and answers
When was Ultracell Suction Sponge cleared by the FDA?
Ultracell Suction Sponge (K972635) received a 510(k) decision of Substantially Equivalent on October 1, 1997, 79 days after the submission was received.
What is the product code of K972635?
The FDA product code is GBX – Catheter, Irrigation, a Class I (low risk) device regulated under 21 CFR 878.4200.