FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUTO SUTURE DISPOSABLE STAPLING INSTRU.
K Number: K780695
·
Decision Jun 22, 1978
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
282
Applicant Total
218
Review Days
59
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Basic Information
- Device Name
- AUTO SUTURE DISPOSABLE STAPLING INSTRU.
- K Number
- K780695
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4750
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- United States Surgical, A Division of Tyco Healthc
- Date Received
- April 24, 1978
- Decision Date
- June 22, 1978
- Product Code
- GDW
- 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 |
|---|---|---|---|
| GDW | Staple, Implantable | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GDW), ordered by most recent decision date.
ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON Circular Stapler (CDH29mm); ETHICON Circular Stapler (CDH33mm); ETHICON Circular Stapler - XL Sealed (ECS21mm); ETHICON Circular Stapler - XL Sealed (ECS25mm); ETHICON Circular Stapler - XL Sealed (ECS29mm); ETHICON Circular Stapler - XL Sealed (ECS33mm)
FDA 510(k)
FDA Class 2
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Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler (EC3DT45S); ETHICON 4000 45mm Long Stapler (EC3DT45L); ETHICON 3D 45mm White Reload (ER45W); ETHICON 3D 45mm Blue Reload (ER45B); ETHICON 3D 45mm Green Reload (ER45G); ETHICON 3D 45mm Black Reload (ER45T)
FDA 510(k)
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ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)
FDA 510(k)
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ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler (GTX60); ECHELON LINEAR Stapler 90mm Stapler (GTX90); ECHELON LINEAR Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR Stapler 3D 90mm Green Reload (GTXR90G)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T)
FDA 510(k)
FDA Class 2
·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 |