FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SCISSORS: THOREK, JORGENSEN, FINOCHIETTO
K Number: K891203
·
Decision Apr 6, 1989
Classifications
1
FEI Numbers
522
Registration Numbers
522
Same Product Code
17
Applicant Total
76
Review Days
31
Basic Information
- Device Name
- SCISSORS: THOREK, JORGENSEN, FINOCHIETTO
- K Number
- K891203
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- ZINNANTI SURGICAL INSTRUMENTS, INC.
- Date Received
- March 6, 1989
- Decision Date
- April 6, 1989
- Product Code
- LRW
- 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 |
|---|---|---|---|
| LRW | Scissors, General, Surgical | FDA class 1 | General, Plastic Surgery |
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| K925957 | SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE | Jun 7, 1994 | Substantially Equivalent |
| K926021 | NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE | Apr 7, 1994 | Substantially Equivalent |
| K925958 | SCISSOR FOR LAPAROSCOPIC SURGERY GU USE | Mar 24, 1994 | Substantially Equivalent |
| K926181 | ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY | Dec 17, 1993 | Substantially Equivalent |
| K925959 | FORCEPS FOR LAPAROSCOPIC SURGERY GU USE | Nov 12, 1993 | Substantially Equivalent |