FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPLATTER CONTROL SHIELD
K Number: K945486
·
Decision Feb 28, 1995
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
16
Review Days
112
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Basic Information
- Device Name
- SPLATTER CONTROL SHIELD
- K Number
- K945486
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Taut, Inc.
- Date Received
- November 8, 1994
- Decision Date
- February 28, 1995
- Product Code
- KKX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Taut, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023261 | ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244 | Dec 13, 2002 | Substantially Equivalent |
| K021731 | ADAPT OPEN ACCESS PORT, MODEL 41233 | Aug 8, 2002 | Substantially Equivalent |
| K011018 | TAUT BALLOON CATHETER, MODEL 50640 | Jun 22, 2001 | Substantially Equivalent |
| K003703 | TAUT-INSUFFLATION NEEDLE | Feb 22, 2001 | Substantially Equivalent |
| K010007 | ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP | Feb 22, 2001 | Substantially Equivalent |
| K992904 | MINI-PORT | Oct 5, 1999 | Substantially Equivalent |
| K992907 | INTRADUCER | Oct 5, 1999 | Substantially Equivalent |
| K972112 | INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 | Dec 1, 1997 | Substantially Equivalent |
| K962003 | TUAT SPLATTER CONTROL SHIELD SCS-300 | Jul 18, 1996 | Substantially Equivalent |
| K960883 | INTRADUCER PERITONEAL CATHETER 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8 | Mar 20, 1996 | Substantially Equivalent |