I-Spouse
FDA 510(k) K953089 · Products For Medicine
510(k) numberK953089
Submission
- Device name
- I-Spouse
- Applicant
- Products For Medicine
Irvine, CA, US - Received
- July 3, 1995
- Decision date
- October 16, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LYU – Accessory, Surgical Apparel
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code LYU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K011755 | Stryker T4 Hytrel (R) TogasLYU · Special | Stryker Corp. | 06/22/2001SE |
| K965237 | Nurses Bouffant CapLYU · Traditional | Copioumed Intl., Inc. | 08/27/1997SE |
| K970988 | Far-East Bouffant CapsLYU · Traditional | Far East Science & Technology Development Co.… | 07/10/1997SE |
| K964364 | Disposable ApronLYU · Traditional | Instrument Makar, Inc. | 02/25/1997SE |
| K961791 | Depuy Disposable Filter/HoodLYU · Traditional | Depuy, Inc. | 08/09/1996SE |
| K961454 | Ammi Magni-GuardLYU · Traditional | American Medical Mfg., Inc. | 07/25/1996SE |
| K945302 | Sloan Sta-Dri Pant ProtectorLYU · Traditional | Sloan Corp. | 03/19/1996SE |
| K954314 | Ultrafit LinersLYU · Traditional | Stahmer Weston Scientific | 12/28/1995SE |
| K952303 | Splash AssistLYU · Traditional | Innovative Outsourcing Solutions | 08/24/1995SE |
| K942200 | Isolyser Orex Surgeon's Caps, Hoods, Bouffant CapsLYU · Traditional | Thantex Specialties, Inc. | 08/07/1995SE |
More from Thantex Specialties, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K963227 | White Sun Light Source Model #: XL300 and #: XL175GCT · Traditional | 10/23/1996SE |
| K955510 | X6000D Silent Sun Light SourceFST · Traditional | 01/31/1996SE |
| K951704 | Non-Woven Filter Paper for Steam and Gas SterilizationFRG · Traditional | 06/28/1995SE |
| K951703 | Tamper Evident Arrows with and Without Sterilization IndicatorsLRT · Traditional | 06/28/1995SE |
| K883658 | I-Spose Eye ShieldFXX · Traditional | 10/25/1988SE |
Questions and answers
When was I-Spouse cleared by the FDA?
I-Spouse (K953089) received a 510(k) decision of Substantially Equivalent on October 16, 1995, 105 days after the submission was received.
What is the product code of K953089?
The FDA product code is LYU – Accessory, Surgical Apparel, a Class I (low risk) device regulated under 21 CFR 878.4040.