FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROSURGE LASER FIBER HOLDER
K Number: K912332
·
Decision Aug 21, 1991
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
15
Review Days
89
Basic Information
- Device Name
- MICROSURGE LASER FIBER HOLDER
- K Number
- K912332
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- MICROSURGE, INC.
- Date Received
- May 24, 1991
- Decision Date
- August 21, 1991
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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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 |
| K933750 | MICROSURGE REUSABLE FRONT END GRASP DEVICES, MODIF | Jun 10, 1994 | Substantially Equivalent |
| K930355 | MICROSURGE SUCTION/IRRIGATION SYSTEM CANNULAS | Jun 8, 1993 | Substantially Equivalent |