Y CONNECTOR
FDA 510(k) clearance K851921 · decided 1985-05-17
Clearance details
- K-number
- K851921
- Device name
- Y CONNECTOR
- Applicant
- Sil-Med Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-05-02
- Decision date
- 1985-05-17
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- GCD
- Device class
- 1
- Regulation number
- 878.4200
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Taunton, 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 |
|---|---|---|
| ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. (K952470) | R-Group Intl. | 1995-11-28 |
| L-CATH CONNECTOR ASSEMBLY (K940198) | Luther Medical Products, Inc. | 1994-12-15 |
| ANGIOMED HIGH PRESSURE CONNECTORS (K863446) | Angiomed U.S., Inc. | 1986-09-23 |
| INCISION DRAIN (K851196) | Sil-Med Corp. | 1985-06-04 |
| CONNECTORS (K760382) | B. Braun Instruments | 1976-11-02 |
| CATHETER CONNECTOR, ARGYLE TUBING (K760524) | Sherwood Medical Industries | 1976-11-02 |
| TUBE, STERILE NON-CONDUCTIVE CONNECTING (K760203) | Ipco Corp. | 1976-07-19 |
Recalls involving this device
No recalls on record reference this clearance.