Awc Butterfly Wound Closures
FDA 510(k) K894802 · American White Cross, Inc.
510(k) numberK894802
Submission
- Device name
- Awc Butterfly Wound Closures
- Applicant
- American White Cross, Inc.
New Rochelle, NY, US - Received
- July 28, 1989
- Decision date
- January 31, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FPX – Strip, Adhesive, Closure, Skin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5240
- Specialty
- General Hospital
Other 510(k)s with product code FPX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K970441 | K-Klosure 2 Inch LENGTH/4 Inch LENGTH/8 Inch LENGTH/12 Inch LengthFPX · Traditional | Medi-Flex Hospital Products, Inc. | 05/09/1997SE |
| K952947 | Delpore Skin ClosureFPX · Traditional | Bitco Intl. | 07/24/1995SE |
| K952702 | Derma SealFPX · Traditional | Ttl Medical | 06/28/1995SE |
| K946321 | Biostrip Sterile Wound Closure StripFPX · Traditional | Cornelia Damsky, Inc. | 01/12/1995SE |
| K931005 | Dukal Skin Closure StripFPX · Traditional | Dukal Corp. | 07/14/1993SE |
| K921775 | Spyroflex Wound ClosuresFPX · Traditional | Polymint Industrial Co. , Ltd. | 05/19/1992SE |
| K894205 | Tecnol Silk StripFPX · Traditional | Tecnol New Jersey Wound Care, Inc. | 07/25/1989SE |
| K874813 | Omed Wound Closure StripsFPX · Traditional | Oxboro Medical Intl., Inc. | 01/29/1988SE |
| K840945 | Skin ClosureFPX · Traditional | Gainor Medical | 10/31/1984SE |
| K842621 | Suture StripFPX · Traditional | Genetic Laboratories, Inc. | 10/25/1984SE |
More from Genetic Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K964614 | Ultrafera Wound DressingKMF · Traditional | 02/06/1997SE |
| K962400 | Air Max External Nasal Dilator StripLWF · Traditional | 09/09/1996SE |
| K854809 | White Cross Sterile Pad 4IN. X 4IN. · Traditional | 01/13/1986SE |
| K853558 | Dosimetric Release/Radiation Steriliz. Absorb Gauz · Traditional | 09/05/1985SE |
| K853334 | Non-Adhera Adhesive Pad 3X4NAD · Traditional | 08/21/1985SE |
| K852412 | Non-Adherent PadEFQ · Traditional | 07/29/1985SE |
| K852408 | Extra Large Adhesive StripsKGX · Traditional | 07/29/1985SE |
| K852462 | Tricot Adhesive BandageKGX · Traditional | 07/26/1985SE |
| K850595 | 3 X 4 Non-Adherent Pad · Traditional | 03/11/1985SE |
Questions and answers
When was Awc Butterfly Wound Closures cleared by the FDA?
Awc Butterfly Wound Closures (K894802) received a 510(k) decision of Substantially Equivalent on January 31, 1990, 187 days after the submission was received.
What is the product code of K894802?
The FDA product code is FPX – Strip, Adhesive, Closure, Skin, a Class I (low risk) device regulated under 21 CFR 880.5240.