FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SUTURE RACK & NEEDLE COUNTER
K Number: K760428
·
Decision Nov 2, 1976
Classifications
1
FEI Numbers
875
Registration Numbers
875
Same Product Code
75
Applicant Total
17
Review Days
81
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Basic Information
- Device Name
- SUTURE RACK & NEEDLE COUNTER
- K Number
- K760428
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Kleen Test Products
- Date Received
- August 13, 1976
- Decision Date
- November 2, 1976
- Product Code
- FSM
- 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 |
|---|---|---|---|
| FSM | Tray, Surgical, Instrument | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FSM), ordered by most recent decision date.
INSTRUMENT TRAY LINER
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SURGICAL INSTRUMENT TRAY
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ARTHROSCOPY TRAY
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OPEN HEART TRAY
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HEART CATH TRAY
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|---|---|---|---|
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| K853622 | SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030 | Oct 10, 1985 | Substantially Equivalent |
| K853454 | SURE COUNT 5 & 10 SPONGE COUNTER | Sep 5, 1985 | Substantially Equivalent |
| K853315 | CAUTERY TIP CLEANING PAD | Aug 21, 1985 | Substantially Equivalent |
| K852258 | SURE-COUNT 30 COUNT MAGNETIC NEEDLE COUNTER | Jun 27, 1985 | Substantially Equivalent |
| K852257 | SURE-COUNT 15 COUNT NEEDLE COUNTER | Jun 26, 1985 | Substantially Equivalent |
| K844199 | ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET | Nov 7, 1984 | Substantially Equivalent |
| K821396 | OUT-RITE WASTE DISPOSABLE BAG | Jun 9, 1982 | Substantially Equivalent |