Antimicrobial Mediastinal Silicone Drain
FDA 510(k) K961194 · Sil-Med Corp.
510(k) numberK961194
Submission
- Device name
- Antimicrobial Mediastinal Silicone Drain
- Applicant
- Sil-Med Corp.
Taunton, MA, US - Received
- March 27, 1996
- Decision date
- August 8, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GBW – Catheter, Peritoneal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
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| K960426 | Medicomp Flexi-Smooth Wound Drainage CatheterGBW · Traditional | Medical Components, Inc. | 03/21/1996SE |
| K942709 | Mediastinal Silicone DrainsGBW · Traditional | Sil-Med Corp. | 01/04/1996SN |
| 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 |
| 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 |
| K921424 | Sil-Med Flat Suction DrainGBX · Traditional | 09/28/1992SE |
Questions and answers
When was Antimicrobial Mediastinal Silicone Drain cleared by the FDA?
Antimicrobial Mediastinal Silicone Drain (K961194) received a 510(k) decision of Substantially Equivalent on August 8, 1996, 134 days after the submission was received.
What is the product code of K961194?
The FDA product code is GBW – Catheter, Peritoneal, a Class I (low risk) device regulated under 21 CFR 878.4200.