FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIATHERMIC SNARE (CRESENT TYPE)
K Number: K792343
·
Decision Dec 18, 1979
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
46
Review Days
29
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Basic Information
- Device Name
- DIATHERMIC SNARE (CRESENT TYPE)
- K Number
- K792343
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Mill-Rose Laboratory
- Date Received
- November 19, 1979
- Decision Date
- December 18, 1979
- 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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| K Number | Device Name | ||
|---|---|---|---|
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| K983124 | MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT | Oct 30, 1998 | Substantially Equivalent |
| K971275 | MILL-ROSE DISPOSABLE POLYPECTOMY SNARE | May 23, 1997 | Substantially Equivalent |
| K962736 | MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE | Jul 29, 1996 | Substantially Equivalent |
| K960880 | MILL-ROSE BLIND MICROBIOLOGY BRUSH | Apr 29, 1996 | Substantially Equivalent |
| K954519 | WANG TRANSENDOSCOPIC ASPIRATION NEEDLE | Dec 22, 1995 | Substantially Equivalent |
| K951600 | MILL-ROSE ROTATABLE POLYPECTOMY SNARE | Dec 18, 1995 | Substantially Equivalent |
| K954745 | MILL-ROSE RIGID SCOPE CLEANING BRUSHES | Nov 27, 1995 | Substantially Equivalent |
| K951051 | RITE-BITE BIOPSY FORCEPS | Mar 24, 1995 | Substantially Equivalent |
| K951048 | RITE-BITE BIOPSY FORCEPS | Mar 15, 1995 | Substantially Equivalent |