Mediastinal Silicone Drains
FDA 510(k) K942709 · Sil-Med Corp.
510(k) numberK942709
Submission
- Device name
- Mediastinal Silicone Drains
- Applicant
- Sil-Med Corp.
Taunton, MA, US - Received
- June 8, 1994
- Decision date
- January 4, 1996
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- GBW – Catheter, Peritoneal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GBW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K992907 | IntraducerGBW · Traditional | Taut, Inc. | 10/05/1999SE |
| K992904 | Mini-PortGBW · Traditional | Taut, Inc. | 10/05/1999SE |
| K972112 | Intraducer Port SC CATALOG#31275,31035,30915, and 31450GBW · Traditional | Taut, Inc. | 12/01/1997SE |
| K961194 | Antimicrobial Mediastinal Silicone DrainGBW · Traditional | Sil-Med Corp. | 08/08/1996SE |
| K960426 | Medicomp Flexi-Smooth Wound Drainage CatheterGBW · Traditional | Medical Components, Inc. | 03/21/1996SE |
| K933510 | Argyle Turkel Safety Trocar Thoracic CatheterGBW · Traditional | Sherwood Medical Co. | 02/24/1994SE |
| K926477 | Bifurcated Suction/Irrigat Tubing Set W/Push ButtoGBW · Traditional | Core Dynamics, Inc. | 11/12/1993SE |
| K913733 | Sterile Chest TubeGBW · Traditional | Vascular Products, Inc. | 10/08/1991SE |
| K894220 | Houts Hysterectomy DrainGBW · Traditional | Helix Medical, Inc. | 08/24/1989SE |
| K894119 | Madegom Ltda. Penrose Drain TubingGBW · Traditional | Madegom | 08/18/1989SE |
More from Madegom
| 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 |
| 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 |
| K921424 | Sil-Med Flat Suction DrainGBX · Traditional | 09/28/1992SE |
Questions and answers
When was Mediastinal Silicone Drains cleared by the FDA?
Mediastinal Silicone Drains (K942709) received a 510(k) decision of Substantially Equivalent for Some Indications on January 4, 1996, 575 days after the submission was received.
What is the product code of K942709?
The FDA product code is GBW – Catheter, Peritoneal, a Class I (low risk) device regulated under 21 CFR 878.4200.