FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RANDALL CURETTE
K Number: K854888
·
Decision Dec 24, 1985
Classifications
1
FEI Numbers
216
Registration Numbers
216
Same Product Code
13
Applicant Total
16
Review Days
18
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Basic Information
- Device Name
- RANDALL CURETTE
- K Number
- K854888
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Euro-Med Intl.
- Date Received
- December 6, 1985
- Decision Date
- December 24, 1985
- Product Code
- FZS
- 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 |
|---|---|---|---|
| FZS | Curette, Surgical, General Use | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FZS), ordered by most recent decision date.
SURGICAL CURETTE
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KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD
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CYMED MICROSKIN(R) DISPOSABLE IRRIGATION SLEEVE
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CURRETTES - PIFFARD, WOLF, VIDAL-SCRAPER
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ACU-CURETTE
FDA 510(k)
FDA Class 1
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ADENOID CURETTE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Euro-Med Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K883884 | PROSTATIC CORE-CUT NEEDLE | Dec 5, 1988 | Substantially Equivalent |
| K882404 | KEVOR-CURETTE | Jul 8, 1988 | Substantially Equivalent |
| K854894 | SPOON | May 2, 1986 | Substantially Equivalent |
| K854891 | KNIFE | May 2, 1986 | Substantially Equivalent |
| K854890 | HOOK PROBE | May 2, 1986 | Substantially Equivalent |
| K854898 | ATLANTIC GRASPER | May 2, 1986 | Substantially Equivalent |
| K854895 | BASKET FORCEP | May 2, 1986 | Substantially Equivalent |
| K854901 | PACIFIC GRASPER | May 2, 1986 | Substantially Equivalent |
| K854897 | MAX-I-GRASP | May 2, 1986 | Substantially Equivalent |
| K854896 | HOOK SCISSOR | May 2, 1986 | Substantially Equivalent |