C-FLEX PENROSE DRAINAGE TUBE
FDA 510(k) clearance K833061 · decided 1983-11-07
Clearance details
- K-number
- K833061
- Device name
- C-FLEX PENROSE DRAINAGE TUBE
- Applicant
- Concept, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-09-09
- Decision date
- 1983-11-07
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- FFA
- Device class
- 2
- Regulation number
- 876.5090
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| CATHETERS, BILIARY CATHETERS, UROLOGICAL (K944290) | Boston Scientific Corp | 1994-12-08 |
| SUCTION TUBE (K864770) | New England Surgical Instrument Corp. | 1987-02-24 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HUNTER-SESSIONS VENA-CAVA OCCLUDER (P770005) | Concept, Inc. | 1977-12-19 |