FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROSURGE REUSABLE FRONT END GRASP DEVICES, MODIF
K Number: K933750
·
Decision Jun 10, 1994
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
15
Review Days
330
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Basic Information
- Device Name
- MICROSURGE REUSABLE FRONT END GRASP DEVICES, MODIF
- K Number
- K933750
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Microsurge, Inc.
- Date Received
- July 15, 1993
- Decision Date
- June 10, 1994
- 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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Other Clearances by Microsurge, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K964109 | MICROSURGE LAPAROSCOPIC PERMACLIP CARTRIDGE WITH IMPLANTABLE CLIP | Nov 27, 1996 | Substantially Equivalent |
| K960554 | DETACHATIP THORACOSCOPIC SCISSORS | Mar 5, 1996 | Substantially Equivalent |
| K955408 | MICROSURGE THORACOSCOPIC INSTRUMENTS | Jan 31, 1996 | Substantially Equivalent |
| K954641 | ENDO-LEADER | Dec 28, 1995 | Substantially Equivalent |
| K954072 | MICROSURGE PUNCTURE CLOSE DEVICE | Oct 26, 1995 | Substantially Equivalent |
| K954520 | MICROSURGE VERESS NEEDLE | Oct 16, 1995 | Substantially Equivalent |
| K953121 | MICROSURGE THORACOSCOPIC ACCESS SYSTEM | Sep 29, 1995 | Substantially Equivalent |
| K951230 | MICROSURGE BIPOLAR GRASPERS | Jun 14, 1995 | Substantially Equivalent |
| K930355 | MICROSURGE SUCTION/IRRIGATION SYSTEM CANNULAS | Jun 8, 1993 | Substantially Equivalent |
| K925830 | MICROSURGE SUCTION/IRRIGATION SYSTEM | May 17, 1993 | Substantially Equivalent |