Y Connector
FDA 510(k) K851921 · Sil-Med Corp.
510(k) numberK851921
Submission
- Device name
- Y Connector
- Applicant
- Sil-Med Corp.
Taunton, MA, US - Received
- May 2, 1985
- Decision date
- May 17, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GCD – Connector, Catheter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GCD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952470 | Acti-Flex Low, Medium, Rescare I, Rescare Ii.GCD · Traditional | R-Group Intl. | 11/28/1995SE |
| K940198 | L-Cath Connector AssemblyGCD · Traditional | Luther Medical Products, Inc. | 12/15/1994SE |
| K863446 | Angiomed High Pressure ConnectorsGCD · Traditional | Angiomed U.S., Inc. | 09/23/1986SE |
| K851196 | Incision DrainGCD · Traditional | Sil-Med Corp. | 06/04/1985SE |
| K760524 | Catheter Connector, Argyle TubingGCD · Traditional | Sherwood Medical Industries | 11/02/1976SE |
| K760382 | ConnectorsGCD · Traditional | B. Braun Instruments | 11/02/1976SE |
| K760203 | Tube, Sterile Non-Conductive ConnectingGCD · Traditional | Ipco Corp. | 07/19/1976SE |
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| K961194 | Antimicrobial Mediastinal Silicone DrainGBW · Traditional | 08/08/1996SE |
| K961295 | Sapphire Line Flat Drain/Kit with Spi-Argent II W/Or W/Out TrocarGBX · Traditional | 06/26/1996SE |
| K960099 | Penrose Drain Models 6001 - 6007GCY · Traditional | 03/11/1996SE |
| K955463 | Grip-A-BootsLXZ · Traditional | 01/23/1996SE |
| K942709 | Mediastinal Silicone DrainsGBW · Traditional | 01/04/1996SN |
| K926496 | Sil-Slip (Coated/Regular(Non-Coated)Thoracic DrainGBX · Traditional | 05/24/1995SE |
| K926495 | Sil-Slip Round Wound Drain (Coated)/Blue StripeGBX · Traditional | 02/02/1994SE |
| K926408 | Sil-Slip Flat Suction DrainGBX · Traditional | 02/02/1994SE |
Questions and answers
When was Y Connector cleared by the FDA?
Y Connector (K851921) received a 510(k) decision of Substantially Equivalent on May 17, 1985, 15 days after the submission was received.
What is the product code of K851921?
The FDA product code is GCD – Connector, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.