FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRECISE BARND PI DISPOSABLE SURGICAL STAPLES
K Number: K911252
·
Decision Jul 25, 1991
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
282
Applicant Total
12
Review Days
126
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Basic Information
- Device Name
- PRECISE BARND PI DISPOSABLE SURGICAL STAPLES
- K Number
- K911252
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4750
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- 3M Medical Products Group
- Date Received
- March 21, 1991
- Decision Date
- July 25, 1991
- 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
·General, Plastic Surgery
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)
FDA Class 2
·General, Plastic Surgery
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
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|---|---|---|---|
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| K952121 | 3M RESIN CEMENT | Jun 22, 1995 | Substantially Equivalent |
| K945726 | 3M(TM) EAR IMPRESSION MATERIAL | Jan 27, 1995 | Substantially Equivalent |
| K941718 | 3M FLUID CONTROL SYSTEM 8300 CASSETTE LOAD | Oct 7, 1994 | Substantially Equivalent |
| K934333 | 3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE | Jul 7, 1994 | Substantially Equivalent |
| K923222 | 3M COLOR LASER IMAGER, MODEL 979 | Sep 30, 1992 | Substantially Equivalent |
| K923075 | 3M LASER IMAGER MODEL 969 | Sep 23, 1992 | Substantially Equivalent |
| K912225 | 3M DIGITAL RECORDING AUTOMATIC FILM HANDLING UNIT | Jul 22, 1991 | Substantially Equivalent |
| K910092 | 3M LASER IMAGER XL | Apr 8, 1991 | Substantially Equivalent |