GBW — Catheter, Peritoneal Class I
FDA product code GBW covers "Catheter, Peritoneal", a Class I medical device regulated under 21 CFR 878.4200. Submissions are reviewed by the General, Plastic Surgery panel. At least 17 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GBW
- Device Class
- Class I
- Regulation Number
- 878.4200
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K992904 | taut | MINI-PORT | October 5, 1999 |
| K992907 | taut | INTRADUCER | October 5, 1999 |
| K972112 | taut | INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 | December 1, 1997 |
| K961194 | sil-med | ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN | August 8, 1996 |
| K960426 | medical components | MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER | March 21, 1996 |
| K942709 | sil-med | MEDIASTINAL SILICONE DRAINS | January 4, 1996 |
| K933510 | sherwood medical | ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETER | February 24, 1994 |
| K926477 | core dynamics | BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO | November 12, 1993 |
| K913733 | vascular products | STERILE CHEST TUBE | October 8, 1991 |
| K894220 | helix medical | HOUTS HYSTERECTOMY DRAIN | August 24, 1989 |
| K894119 | madegom | MADEGOM LTDA. PENROSE DRAIN TUBING | August 18, 1989 |
| K854812 | research medical | NELSON-JUNG PLEURAL CATH | February 11, 1986 |
| K843575 | sil-med | DERBYSHIRE DRAIN | October 24, 1984 |
| K813063 | sil-med | FLAT DRAIN | December 18, 1981 |
| K811627 | arrow intl | ARROW PERITONEAL LAVAGE CATHERIZATION K | August 10, 1981 |
| K811378 | medi-tech | PERCUTANEOUS DRAINING CATHETER | June 2, 1981 |
| K800422 | a.d.t. lab industries | ADT MINI PERITONEAL LAVAGE KIT | March 12, 1980 |