Intraducer
FDA 510(k) K992907 · Taut, Inc.
510(k) numberK992907
Submission
- Device name
- Intraducer
- Applicant
- Taut, Inc.
Geneva, IL, US - Received
- August 30, 1999
- Decision date
- October 5, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code GBW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
|---|---|---|
| K023261 | Adapt Balloon Open Access Port, Model 41244GCJ · Traditional | 12/13/2002SE |
| K021731 | Adapt Open Access Port, Model 41233GCJ · Traditional | 08/08/2002SE |
| K011018 | Taut Balloon Catheter, Model 50640GCA · Traditional | 06/22/2001SE |
| K010007 | Adapt Laparoscopic Port & Adapt Reducer CapGCJ · Traditional | 02/22/2001SE |
| K003703 | Taut-Insufflation NeedleHIF · Traditional | 02/22/2001SE |
| K992904 | Mini-PortGBW · Traditional | 10/05/1999SE |
| K972112 | Intraducer Port SC CATALOG#31275,31035,30915, and 31450GBW · Traditional | 12/01/1997SE |
| K962003 | Tuat Splatter Control Shield SCS-300KKX · Traditional | 07/18/1996SE |
| K960883 | Intraducer Peritoneal Catheter 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8GCJ · Traditional | 03/20/1996SE |
| K945486 | Splatter Control ShieldKKX · Traditional | 02/28/1995SE |
Questions and answers
When was Intraducer cleared by the FDA?
Intraducer (K992907) received a 510(k) decision of Substantially Equivalent on October 5, 1999, 36 days after the submission was received.
What is the product code of K992907?
The FDA product code is GBW – Catheter, Peritoneal, a Class I (low risk) device regulated under 21 CFR 878.4200.