FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SHARTPOINT EYED NEEDLES
K Number: K813589
·
Decision Jan 18, 1982
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
4
Applicant Total
16
Review Days
21
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Basic Information
- Device Name
- SHARTPOINT EYED NEEDLES
- K Number
- K813589
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- S. Jackson, Inc.
- Date Received
- December 28, 1981
- Decision Date
- January 18, 1982
- Product Code
- GDL
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GDL | Needle, Suturing, Reusable | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GDL), ordered by most recent decision date.
NON-STERILE SUTURE NEEDLES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
25-420 TO 25-436 VARIOUS TYPES OF SUTURE NEEDLES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
25-450 TO 25-540 VARIOUS SUTURE FORCEPS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
UNIVERSAL SUTURE PASSER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by S. Jackson, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K080216 | SUPRAMESH EXTRA | Sep 15, 2008 | Substantially Equivalent |
| K973379 | STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS | Sep 25, 1997 | Substantially Equivalent |
| K931614 | MOPYLEN SUTURE | Dec 17, 1993 | Substantially Equivalent |
| K931613 | SUPRAMID SUTURE | Dec 17, 1993 | Substantially Equivalent |
| K931612 | NYLAMID SUTURE | Dec 17, 1993 | Substantially Equivalent |
| K922630 | MOPYLEN | Oct 20, 1992 | Substantially Equivalent |
| K912429 | N80-838 SUPRAMID EXTRA SUTURE | Oct 2, 1991 | Substantially Equivalent |
| K904052 | SUPRAMID EXTRA SUTURES | Oct 25, 1990 | Substantially Equivalent |
| K852011 | NYLAMID MESH PAD FULL & HALF | Jun 11, 1985 | Substantially Equivalent |
| K831725 | FOIL IN 3 FORMS-NON-STERILE SHEETS | Aug 16, 1983 | Substantially Equivalent |