FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDO-GLIDE
K Number: K013701
·
Decision Feb 4, 2002
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
14
Review Days
88
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Basic Information
- Device Name
- ENDO-GLIDE
- K Number
- K013701
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sonotech, Inc.
- Date Received
- November 8, 2001
- Decision Date
- February 4, 2002
- 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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Other Clearances by Sonotech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042619 | ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT | Nov 5, 2004 | Substantially Equivalent |
| K033178 | ULTRABIO | Aug 4, 2004 | Substantially Equivalent |
| K031222 | SCANLUBE | Jul 23, 2003 | Substantially Equivalent |
| K031894 | SCANTEC PAD | Jul 18, 2003 | Substantially Equivalent |
| K013170 | SCANTAC MEMBRANE OR SCANTAC STRIP | Nov 13, 2001 | Substantially Equivalent |
| K984562 | VIVOSONIC | Jun 8, 1999 | Substantially Equivalent |
| K983691 | SCANFLEX SOLID COUPLANT MEMBRANE | May 5, 1999 | Substantially Equivalent |
| K983985 | HYBRISONIC SHEATH | Feb 25, 1999 | Substantially Equivalent |
| K981028 | ULTRA IMAGE AND ULTRA SCAN | Aug 21, 1998 | Substantially Equivalent |
| K964658 | OASIS | Feb 14, 1997 | Substantially Equivalent |