Silicone Sump Drain
FDA 510(k) K862767 · Sil-Med Corp.
510(k) numberK862767
Submission
- Device name
- Silicone Sump Drain
- Applicant
- Sil-Med Corp.
Taunton, MA, US - Received
- July 22, 1986
- Decision date
- August 7, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GBS – Catheter, Ventricular, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GBS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K912645 | Atriums PDR Thoracic CatheterGBS · Traditional | Atrium Medical Corp. | 09/13/1991SE |
| K883887 | Axiom Atraum Wound DrainsGBS · Traditional | Axiom, Inc. | 02/17/1989SE |
| K881873 | Introduction/Drainage Catheter & AccessGBS · Traditional | Sheridan Catheter Corp. | 05/18/1988SE |
| K880895 | Uresil Wound Drain TrocarGBS · Traditional | Uresil Corp. | 03/14/1988SE |
| K880376 | Novo Vivo Suction Catheter Vessel W/Mucose TrapGBS · Traditional | Genesis Industries, Inc. | 02/16/1988SE |
| K873377 | Closed Chest Drainage Set W/SuturesGBS · Traditional | Gish Biomedical, Inc. | 10/28/1987SE |
| K872460 | AN3000 Mahoney DrainGBS · Traditional | H.W. Andersen Products, Inc. | 07/23/1987SE |
| K872459 | AN3100 Mulholland DrainGBS · Traditional | H.W. Andersen Products, Inc. | 07/21/1987SE |
| K872457 | AN3500 Worth DrainGBS · Traditional | H.W. Andersen Products, Inc. | 07/21/1987SE |
| K870015 | Hci All Purpose Drain/Catheter SetGBS · Traditional | Health Care Innovations, Inc. | 02/06/1987SE |
More from Health Care Innovations, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K972521 | Navigator (Stylet) 2006GAH · Traditional | 10/01/1997SE |
| K961392 | Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent IIFJS · Traditional | 07/18/1997SE |
| 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 Silicone Sump Drain cleared by the FDA?
Silicone Sump Drain (K862767) received a 510(k) decision of Substantially Equivalent on August 7, 1986, 16 days after the submission was received.
What is the product code of K862767?
The FDA product code is GBS – Catheter, Ventricular, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4200.