FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SUTURE CLIP APPLIER/REMOVER
K Number: K890233
·
Decision Jan 27, 1989
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
13
Applicant Total
63
Review Days
9
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Basic Information
- Device Name
- SUTURE CLIP APPLIER/REMOVER
- K Number
- K890233
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Kinetic Medical Products
- Date Received
- January 18, 1989
- Decision Date
- January 27, 1989
- Product Code
- GDO
- 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 |
|---|---|---|---|
| GDO | Applier, Surgical, Clip | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GDO), ordered by most recent decision date.
UNICLIP SURGICAL CLIP APPLIER
FDA 510(k)
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MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APP
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FDA Class 1
·General, Plastic Surgery
TOWEL CLIPS
FDA 510(k)
FDA Class 1
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DISPOSABLE MULTIPLE LIGATING CLIP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ETHICON MULTIPLE LIGATING CLIP APPLIER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HEMOSPENSER CARTRIDGE CAT. NO. 523500-
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Kinetic Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K890385 | MIDWIFERY/OBSTETRICAL FORCEPS | Mar 1, 1989 | Substantially Equivalent |
| K890387 | MALLEABLE PLACENTA CURETTE | Feb 27, 1989 | Substantially Equivalent |
| K890380 | CERVICAL BIOPSY FORCEPS | Feb 27, 1989 | Substantially Equivalent |
| K890382 | COMPRESSION FORCEPS | Feb 27, 1989 | Substantially Equivalent |
| K890376 | VAGINAL SPECULUM | Feb 27, 1989 | Substantially Equivalent |
| K890383 | HYSTERECTOMY FORCEPS | Feb 16, 1989 | Substantially Equivalent |
| K890216 | MICROSURGICAL KERATOME | Feb 16, 1989 | Substantially Equivalent |
| K890378 | UTERINE DRESSING FORCEPS | Feb 13, 1989 | Substantially Equivalent |
| K890379 | UTERINE TENTACULUM | Feb 13, 1989 | Substantially Equivalent |
| K890389 | UMBILICAL SCISSORS | Feb 13, 1989 | Substantially Equivalent |