FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOSCOPIC CLIP APPLIER
K Number: K962493
·
Decision Sep 11, 1996
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
68
Applicant Total
174
Review Days
77
Basic Information
- Device Name
- ENDOSCOPIC CLIP APPLIER
- K Number
- K962493
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AESCULAP, INC.
- Date Received
- June 26, 1996
- Decision Date
- September 11, 1996
- Product Code
- OCW
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| OCW | Endoscopic Tissue Approximation Device | FDA class 2 | Gastroenterology, Urology |
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|---|---|---|---|
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| K151696 | Caiman Seal and Cut Technology | Jul 20, 2015 | Substantially Equivalent |
| K142970 | SterilContainer S System | Jul 8, 2015 | Substantially Equivalent |
| K141687 | AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM | Apr 2, 2015 | Substantially Equivalent |
| K142315 | MINOP Disposable Introducer 26F | Nov 14, 2014 | Substantially Equivalent |
| K133890 | AESCULAP OPTILENE NONABSORBABLE SUTURE | Jul 15, 2014 | Substantially Equivalent |