FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICRODISCECTOMY CURETTE SET
K Number: K875292
·
Decision Jan 29, 1988
Classifications
1
FEI Numbers
216
Registration Numbers
216
Same Product Code
13
Applicant Total
27
Review Days
30
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Basic Information
- Device Name
- MICRODISCECTOMY CURETTE SET
- K Number
- K875292
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- T. Korossurgical Instruments Corp.
- Date Received
- December 30, 1987
- Decision Date
- January 29, 1988
- 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
·General, Plastic Surgery
ADENOID CURETTE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by T. Korossurgical Instruments Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K001915 | GRAFT MARKER RING | Apr 27, 2001 | Substantially Equivalent |
| K002755 | NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE | Dec 4, 2000 | Substantially Equivalent |
| K954016 | VIDEOSCOPE W/IRRIGATION SHEATH | Jan 25, 1996 | Substantially Equivalent for Some Indications |
| K953998 | DISCETOME TISSUE ASPIRATOR | Dec 4, 1995 | Substantially Equivalent |
| K954052 | ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES | Nov 6, 1995 | Substantially Equivalent for Some Indications |
| K954014 | PERCUTANEOUS DISCECTOMY CANNULA SYSTEM | Nov 6, 1995 | Substantially Equivalent for Some Indications |
| K935529 | CERVICAL SELF-RETAINING RETRACTOR | Mar 22, 1994 | Substantially Equivalent |
| K926585 | THOROCOSCOPY SELF-RETAINING RETRACTOR | Aug 6, 1993 | Substantially Equivalent |
| K931262 | REUSABLE/INTERCHANGEABLE SHAFT, ENDOSCOPIC SCISSOR | Aug 6, 1993 | Substantially Equivalent |
| K926583 | REUSABLE ENDOSCOPIC SCISSORS, GRASPER-MONOPOLAR | Aug 6, 1993 | Substantially Equivalent |