Neuro Sponge
FDA 510(k) K840541 · Surgicot, Inc.
510(k) numberK840541
Submission
- Device name
- Neuro Sponge
- Applicant
- Surgicot, Inc.
Mchenry, IL, US - Received
- February 8, 1984
- Decision date
- April 23, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
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| K931270 | Surgiclean Enzymatic Instrument CleanerFLG · Traditional | 04/13/1994SE |
| K863122 | Assert Biological/Chemical Indicator 12 Month Exp.FRC · Traditional | 12/17/1986SE |
| K855101 | Assert TM Biological/Chemical IndicatorFRC · Traditional | 07/17/1986SE |
| K854631 | Assert Eo Biological Test PackFRC · Traditional | 05/27/1986SE |
| K854902 | Surgicot Steam Test PackFRC · Traditional | 05/20/1986SE |
| K840471 | Eye SpearHOZ · Traditional | 03/16/1984SE |
| K840470 | Surgiscribe Marking PenFZZ · Traditional | 03/12/1984SE |
| K830739 | Pro-GuardFRG · Traditional | 03/29/1983SE |
| K820302 | Surgipeel Self-Seal Packaging SystemFRG · Traditional | 02/24/1982SE |
Questions and answers
When was Neuro Sponge cleared by the FDA?
Neuro Sponge (K840541) received a 510(k) decision of Substantially Equivalent on April 23, 1984, 75 days after the submission was received.
What is the product code of K840541?
The FDA product code is GDY – Gauze/Sponge, Internal, X-Ray Detectable, a Class I (low risk) device regulated under 21 CFR 878.4450.