FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GYRUS PLASMACISION LAPAROSCOPIC SPATULA
K Number: K041633
·
Decision Oct 22, 2004
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
15
Review Days
128
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Basic Information
- Device Name
- GYRUS PLASMACISION LAPAROSCOPIC SPATULA
- K Number
- K041633
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gyrus Medical, Inc.
- Date Received
- June 16, 2004
- Decision Date
- October 22, 2004
- Product Code
- GEI
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Gyrus Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K050550 | GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR | Nov 9, 2005 | Substantially Equivalent |
| K050460 | GYRUS PLASMACISION AND PLASMABLEND ELECTRODES | Oct 25, 2005 | Substantially Equivalent |
| K041999 | GYRUS PLASMA SKIN RESURFACING SYSTEM | Mar 2, 2005 | Substantially Equivalent |
| K024286 | GYRUS OPEN FORCEPS | Nov 17, 2003 | Substantially Equivalent |
| K031085 | GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES) | Jul 21, 2003 | Substantially Equivalent |
| K031079 | EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE | May 21, 2003 | Substantially Equivalent |
| K031081 | EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS | May 21, 2003 | Substantially Equivalent |
| K031082 | EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK | May 21, 2003 | Substantially Equivalent |
| K031080 | EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS DISSECTING FORCEPS | May 16, 2003 | Substantially Equivalent |
| K031078 | EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO & MOLLY FORCEPS | May 16, 2003 | Substantially Equivalent |