FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARRIER, LIGATURE (79 GEJ)
K Number: K944465
·
Decision Sep 28, 1994
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
15
Review Days
16
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Basic Information
- Device Name
- CARRIER, LIGATURE (79 GEJ)
- K Number
- K944465
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Endotec, Inc.
- Date Received
- September 12, 1994
- Decision Date
- September 28, 1994
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)
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Other Clearances by Endotec, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K081400 | FANNING-PAPPAS MODULAR KNEE BEARING | Feb 20, 2009 | Substantially Equivalent |
| K012702 | BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 | Jan 30, 2002 | Substantially Equivalent |
| K992394 | BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT | Oct 15, 1999 | Substantially Equivalent |
| K982418 | BUECHEL-PAPPAS MODULAR SALVAGE STEM | Apr 29, 1999 | Substantially Equivalent |
| K963101 | B-P HEMISPHERICAL ACETABULAR COMPONENT | Feb 12, 1997 | Substantially Equivalent |
| K963100 | TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP | Feb 12, 1997 | Substantially Equivalent |
| K960425 | BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX | Oct 3, 1996 | Substantially Equivalent |
| K960424 | BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD | Aug 26, 1996 | Substantially Equivalent |
| K945254 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES | Jun 6, 1995 | Substantially Equivalent |
| K944414 | DEKALB | Sep 27, 1994 | Substantially Equivalent |