FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REUSABLE/INTERCHANGEABLE SHAFT, ENDOSCOPIC SCISSOR
K Number: K931262
·
Decision Aug 6, 1993
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
27
Review Days
151
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Basic Information
- Device Name
- REUSABLE/INTERCHANGEABLE SHAFT, ENDOSCOPIC SCISSOR
- K Number
- K931262
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- T. Korossurgical Instruments Corp.
- Date Received
- March 8, 1993
- Decision Date
- August 6, 1993
- 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 T. Korossurgical Instruments Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K001915 | GRAFT MARKER RING | Apr 27, 2001 | Substantially Equivalent |
| K002755 | NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE | Dec 4, 2000 | Substantially Equivalent |
| K954016 | VIDEOSCOPE W/IRRIGATION SHEATH | Jan 25, 1996 | Substantially Equivalent for Some Indications |
| K953998 | DISCETOME TISSUE ASPIRATOR | Dec 4, 1995 | Substantially Equivalent |
| K954052 | ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES | Nov 6, 1995 | Substantially Equivalent for Some Indications |
| K954014 | PERCUTANEOUS DISCECTOMY CANNULA SYSTEM | Nov 6, 1995 | Substantially Equivalent for Some Indications |
| K935529 | CERVICAL SELF-RETAINING RETRACTOR | Mar 22, 1994 | Substantially Equivalent |
| K926585 | THOROCOSCOPY SELF-RETAINING RETRACTOR | Aug 6, 1993 | Substantially Equivalent |
| K926583 | REUSABLE ENDOSCOPIC SCISSORS, GRASPER-MONOPOLAR | Aug 6, 1993 | Substantially Equivalent |
| K931259 | ENDOSCOPIC OR THORASCOPIC FORCEPS | Jun 8, 1993 | Substantially Equivalent |