FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JARIT SURGICAL INSTRUMENTS
K Number: K931928
·
Decision Nov 10, 1993
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
11
Review Days
208
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Basic Information
- Device Name
- JARIT SURGICAL INSTRUMENTS
- K Number
- K931928
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- J. Jamner Surgical Instruments, Inc.
- Date Received
- April 16, 1993
- Decision Date
- November 10, 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 J. Jamner Surgical Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K082349 | JARIT HULKA UTERINE TENACULUM FORCEPS | Nov 21, 2008 | Substantially Equivalent |
| K944670 | JARIT RECOMMENDED SINUS INSTRUMENTS | Feb 2, 1995 | Substantially Equivalent |
| K944870 | JARIT ENDOSCOPES, MODELS 600-600; 600-630; 600-650; AND 600-680 | Nov 2, 1994 | Substantially Equivalent |
| K941565 | JARIT RECOMMENDED SINUS INSTRUMENTS | May 16, 1994 | Substantially Equivalent |
| K932456 | JARIT SURGICAL INSTRUMENTS | Apr 21, 1994 | Substantially Equivalent |
| K933728 | JARIT SURGICAL INSTRUMENTS: CATALOG 615-330, 615-331, 615-334, 615-335, 615-338, 615-339 | Feb 23, 1994 | Substantially Equivalent |
| K931959 | JARIT SURGICAL INSTRUMENTS | Oct 5, 1993 | Substantially Equivalent |
| K931878 | JARIT ENDOSCOPES, 600-600; 600-630; 600-650; 680 | Aug 19, 1993 | Substantially Equivalent |
| K771625 | LEININGEO AORTIC PUNCH #310-395 & 397 | Sep 12, 1977 | Substantially Equivalent |
| K771624 | COPE LUNG FORCEPS #305-218 | Sep 6, 1977 | Substantially Equivalent |