FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUTO SUTURE STAINLESS STEEL SUTURES*
K Number: K872532
·
Decision Aug 5, 1987
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
3
Applicant Total
218
Review Days
40
Basic Information
- Device Name
- AUTO SUTURE STAINLESS STEEL SUTURES*
- K Number
- K872532
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4495
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
- Date Received
- June 26, 1987
- Decision Date
- August 5, 1987
- Product Code
- GAO
- 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 |
|---|---|---|---|
| GAO | Suture, Nonabsorbable | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAO), ordered by most recent decision date.
LABELING FOR MYO/WIRE II STERNOTOMY SUTURES
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SHARPOINT STAINLESS STEEL SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DISARP ORIGINAL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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| K061095 | AUTO SUTUR ENDO GIA STAPLERS | May 31, 2006 | Substantially Equivalent |
| K050947 | MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE | Jun 1, 2005 | Substantially Equivalent |
| K042412 | MODIFIED SPACEMAKER SYSTEM | Sep 24, 2004 | Substantially Equivalent |
| K040594 | HERCULON SOFT TISSUE REATTACHMENT SYSTEM | Mar 31, 2004 | Substantially Equivalent |
| K032696 | AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT | Dec 1, 2003 | Substantially Equivalent |