FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORS
K Number: K991928
·
Decision Jun 25, 1999
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
63
Review Days
17
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Basic Information
- Device Name
- MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORS
- K Number
- K991928
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Allegiance Healthcare Corp.
- Date Received
- June 8, 1999
- Decision Date
- June 25, 1999
- 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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| K Number | Device Name | ||
|---|---|---|---|
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| K024120 | MODIFICATION TO TEMNO BIOPSY NEEDLES | Jan 15, 2003 | Substantially Equivalent |
| K024292 | MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM | Jan 9, 2003 | Substantially Equivalent |
| K024102 | DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM | Dec 18, 2002 | Substantially Equivalent |
| K023425 | DRAPES WITH ABSORBENT REINFORCEMENT | Nov 6, 2002 | Substantially Equivalent |
| K022765 | NITRILE POWDER-FREE EXAMINATION GLOVES | Oct 11, 2002 | Substantially Equivalent |
| K023170 | NITRILE POWDER-FREE EXAMINATION GLOVES | Oct 9, 2002 | Substantially Equivalent |
| K023167 | BREATHABLE SURGICAL GOWN | Oct 2, 2002 | Substantially Equivalent |
| K012931 | GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM | Aug 20, 2002 | Substantially Equivalent |