SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP
FDA 510(k) clearance K954116 · decided 1995-11-06
Clearance details
- K-number
- K954116
- Device name
- SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP
- Applicant
- Technical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-07-20
- Decision date
- 1995-11-06
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- FEW
- Device class
- 2
- Regulation number
- 876.5090
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Decatur, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| UNIVERSA PERCULTANEOUS DRAINAGE CATHETER (K140085) | Cook Incorporated | 2014-11-18 |
| BARD MALECOT AND PEZZER DRAINS (K070879) | C.R. Bard, Inc. | 2007-04-24 |
| MANAN MALECOT BASKET DRAINAGE CATHETER (K981258) | Medical Device Technologies, Inc. | 1998-04-22 |
| MANAN MALECOT BASKET DRAINAGE CATHETER (K954147) | Manan Medical Products, Inc. | 1996-03-26 |
| OLYMPIC SMART SCALE CARE CENTER (K920423) | Olympic Medical Corp. | 1992-06-11 |
Recalls involving this device
No recalls on record reference this clearance.