Needle, Suturing, Disposable
The Needle, Suturing, Disposable (product code GAB) is a single-use needle employed during surgical procedures to pass suture material through tissue for the purpose of wound closure or tissue approximation in general and plastic surgery. It is classified as FDA Class 1, posing minimal risk, requiring only general controls and no premarket notification. The device is regulated under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
Research product code GAB in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- GAB
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K012199 | DIGICAP | Dec 19, 2001 | Substantially Equivalent | Humana USA, Inc. |
| K980988 | AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) | May 11, 1998 | Substantially Equivalent | Axya Medical, Inc. |
| K932591 | ENDO-JUDGE | Dec 22, 1993 | Substantially Equivalent | Synergistic Medical Technologies, Inc. |
| K895681 | CONTRAST BACKGROUND MATERIAL | Oct 24, 1989 | Substantially Equivalent | Applied Medical Technologies |
| K863595 | COATED SUTURE NEEDLE | Oct 24, 1986 | Substantially Equivalent | Sharpoint, Inc. |
| K831648 | ANCHOR BRAND SURGICAL NEEDLES | Aug 16, 1983 | Substantially Equivalent | Anchor Products Co. |
| K812444 | RADIATION STERILIZATION FOR NEEDLE CNTR | Dec 14, 1981 | Substantially Equivalent | Devon Industries, Inc. |
| K801976 | SCANLAN STERNUM NEEDLE-SUTURE | Sep 26, 1980 | Substantially Equivalent | Scanlan Intl., Inc. |
FEI Numbers
This FDA classification entry is associated with 122 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 122 registration numbers. Click on an entry to view related FDA registrations.