FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
K Number: K963160
·
Decision Jun 27, 1997
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
62
Applicant Total
149
Review Days
317
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Basic Information
- Device Name
- HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
- K Number
- K963160
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4400
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Olympus America, Inc.
- Date Received
- August 14, 1996
- Decision Date
- June 27, 1997
- Product Code
- PKL
- 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 |
|---|---|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PKL), ordered by most recent decision date.
Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)
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