Suture, Nonabsorbable
The Suture, Nonabsorbable (product code GAO) is a permanent suture material that is not broken down by the body, used in general and plastic surgery to provide long-term tissue approximation or closure, and may require removal after healing or remain in place permanently. It is classified as FDA Class 2, requiring a 510(k) premarket notification to demonstrate substantial equivalence. The device is regulated under 21 CFR 878.4495 in the General, Plastic Surgery specialty (SU). This device carries an implant designation, as it is placed within or through body tissue.
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Basic Information
- Product Code
- GAO
- Device Class
- FDA class 2
- Regulation Number
- 878.4495
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K932513 | LABELING FOR MYO/WIRE II STERNOTOMY SUTURES | Jan 07, 1994 | Substantially Equivalent | Alto Development Corp. |
| K872532 | AUTO SUTURE STAINLESS STEEL SUTURES* | Aug 05, 1987 | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc |
| K863034 | SHARPOINT STAINLESS STEEL SUTURE | Sep 30, 1986 | Substantially Equivalent | Chathamborough Research Group, Inc. |
| K802248 | DISARP ORIGINAL | Sep 26, 1980 | Substantially Equivalent | Unoplast A/S |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.