FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3-RING HANDLE, GRASP FORCEPS, LOOP RETRIE., BASKET
K Number: K894986
·
Decision Dec 1, 1989
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
73
Applicant Total
16
Review Days
115
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Basic Information
- Device Name
- 3-RING HANDLE, GRASP FORCEPS, LOOP RETRIE., BASKET
- K Number
- K894986
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- North American Sterilization & Packaging Co.
- Date Received
- August 8, 1989
- Decision Date
- December 1, 1989
- Product Code
- OCZ
- 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 |
|---|---|---|---|
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by North American Sterilization & Packaging Co.
| K Number | Device Name | ||
|---|---|---|---|
| K964231 | NASP HYDROCOLLOID DRESSING (REGULAR OR THIN) | Mar 10, 1997 | Substantially Equivalent |
| K963753 | NASP TRANSPARENT DRESSING | Nov 29, 1996 | Substantially Equivalent |
| K962352 | HYDROGEL SKIN DRESSING | Aug 2, 1996 | Substantially Equivalent |
| K925588 | NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI | Dec 3, 1993 | Substantially Equivalent |
| K925593 | NORTEC STERILE WATER FOR DEVICE IRRIGATION | Dec 3, 1993 | Substantially Equivalent |
| K925161 | NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO | Jul 21, 1993 | Substantially Equivalent |
| K911865 | NORTEC CONNECTING TUBE SET | Nov 1, 1991 | Substantially Equivalent |
| K911784 | NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY | Sep 23, 1991 | Substantially Equivalent |
| K910691 | NORTEC URETERAL STENT | Aug 15, 1991 | Substantially Equivalent |
| K903162 | FLEXIBLE ENDOSCOPIC ELECTRODES | Dec 18, 1990 | Substantially Equivalent |