Needle, Suturing, Reusable
The Needle, Suturing, Reusable (product code GDL) is a reusable surgical needle designed to pass suture material through tissue for wound closure or tissue approximation in general and plastic surgery, intended to be sterilized and used across multiple procedures. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and not requiring 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.
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Basic Information
- Product Code
- GDL
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K881394 | NON-STERILE SUTURE NEEDLES | Apr 08, 1988 | Substantially Equivalent | China National Medicines C/O Havel'S |
| K851782 | 25-450 TO 25-540 VARIOUS SUTURE FORCEPS | Jun 20, 1985 | Substantially Equivalent | Artiberia |
| K851781 | 25-420 TO 25-436 VARIOUS TYPES OF SUTURE NEEDLES | Jun 20, 1985 | Substantially Equivalent | Artiberia |
| K813589 | SHARTPOINT EYED NEEDLES | Jan 18, 1982 | Substantially Equivalent | S. Jackson, Inc. |
| K812566 | UNIVERSAL SUTURE PASSER | Nov 10, 1981 | Substantially Equivalent | Ortho Pared Instruments, Inc. |
FEI Numbers
This FDA classification entry is associated with 83 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 83 registration numbers. Click on an entry to view related FDA registrations.