SUCTION TUBE
FDA 510(k) clearance K864770 · decided 1987-02-24
Clearance details
- K-number
- K864770
- Device name
- SUCTION TUBE
- Applicant
- New England Surgical Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-12-05
- Decision date
- 1987-02-24
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- FFA
- Device class
- 2
- Regulation number
- 876.5090
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Rockland, MA, 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 |
| C-FLEX PENROSE DRAINAGE TUBE (K833061) | Concept, Inc. | 1983-11-07 |
Recalls involving this device
No recalls on record reference this clearance.