FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244
K Number: K023261
·
Decision Dec 13, 2002
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
16
Review Days
74
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Basic Information
- Device Name
- ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244
- K Number
- K023261
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Taut, Inc.
- Date Received
- September 30, 2002
- Decision Date
- December 13, 2002
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Taut, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K945486 | SPLATTER CONTROL SHIELD | Feb 28, 1995 | Substantially Equivalent |