Gore-Tex Surgical Tape
FDA 510(k) K894580 · W. L. Gore & Associates, Inc.
510(k) numberK894580
Submission
- Device name
- Gore-Tex Surgical Tape
- Applicant
- W. L. Gore & Associates, Inc.
Flagstaff, AZ, US - Received
- July 24, 1989
- Decision date
- October 10, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FTM – Mesh, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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Questions and answers
When was Gore-Tex Surgical Tape cleared by the FDA?
Gore-Tex Surgical Tape (K894580) received a 510(k) decision of Substantially Equivalent on October 10, 1989, 78 days after the submission was received.
What is the product code of K894580?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.