FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SUTURE REMOVAL KIT
K Number: K910361
·
Decision Mar 27, 1991
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
14
Applicant Total
50
Review Days
57
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Basic Information
- Device Name
- SUTURE REMOVAL KIT
- K Number
- K910361
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Megadyne Medical Products, Inc.
- Date Received
- January 29, 1991
- Decision Date
- March 27, 1991
- Product Code
- MCZ
- 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 |
|---|---|---|---|
| MCZ | Suture Removal Kit | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MCZ), ordered by most recent decision date.
AMSINO SUTURE REMOVAL KIT
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PROD. NO. 01-132 - SUTURE REMOVAL KIT
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GRAND MEDICAL SUTURE REMOVAL KIT
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SKIN STAPLE REMOVAL TRAYS
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SUTURE REMOVAL KIT
FDA 510(k)
FDA Class 1
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CARAPACE INCISION AND DRAINAGE TRAYS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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| K193145 | Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch | Mar 24, 2020 | Substantially Equivalent |
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| K141587 | E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA FILTER, CHARCOAL FILTER, ADAPTER | Feb 18, 2015 | Substantially Equivalent |
| K133726 | MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE | Jan 24, 2014 | Substantially Equivalent |
| K080741 | MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE | Dec 16, 2008 | Substantially Equivalent |
| K081791 | E-Z CLEAN ELECTROSURGICAL ELECTRODE | Oct 21, 2008 | Substantially Equivalent |
| K072559 | SUCTION COAGULATOR | Oct 5, 2007 | Substantially Equivalent |