FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APP
K Number: K890941
·
Decision Apr 7, 1989
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
13
Applicant Total
218
Review Days
43
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Basic Information
- Device Name
- MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APP
- K Number
- K890941
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- United States Surgical, A Division of Tyco Healthc
- Date Received
- February 23, 1989
- Decision Date
- April 7, 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
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ETHICON MULTIPLE LIGATING CLIP APPLIER
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HEMOSPENSER CARTRIDGE CAT. NO. 523500-
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by United States Surgical, A Division of Tyco Healthc
| K Number | Device Name | ||
|---|---|---|---|
| K071406 | AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER | Nov 21, 2007 | Substantially Equivalent |
| K071920 | AUTOSUTURE ABSORBABLE TACK AND APPLICATOR | Sep 28, 2007 | Substantially Equivalent |
| K061288 | AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER | Nov 2, 2006 | Substantially Equivalent |
| K062850 | AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS | Oct 23, 2006 | Substantially Equivalent |
| K062326 | AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE | Sep 1, 2006 | Substantially Equivalent |
| 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 |