Dobbhoff Enteric Feeding Bag
FDA 510(k) K781385 · Biosearch Medical Products, Inc.
510(k) numberK781385
Submission
- Device name
- Dobbhoff Enteric Feeding Bag
- Applicant
- Biosearch Medical Products, Inc.
Mchenry, IL, US - Received
- August 11, 1978
- Decision date
- September 7, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FPD – Tube, Feeding
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FPD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243361 | NutrifitFPD · Traditional | Vygon USA | 12/19/2024SE |
| K180236 | VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)FPD · Traditional | Vr Medical Technology Co., Ltd. | 01/18/2019SE |
| K131590 | Innersense Esophageal Temperature Probe / Feeding TubeFPD · Traditional | Philips Medical Systems | 10/23/2013SE |
| K120815 | Innersense Esophageal Temperature/Feeding TubeFPD · Traditional | Philips Medical Systems | 03/06/2013SE |
| K121105 | Nutrisafe 2 Feeding TubeFPD · Traditional | Vygon Corp. | 12/18/2012SE |
| K100163 | Nutrisafe 2 Feeding Tubes Model 362.XXX. 1362.XXXFPD · Traditional | Vygon Corp. | 10/13/2011SE |
| K110853 | VR Medical Enteral Oral SyringeFPD · Traditional | Vr Medical | 05/13/2011SE |
| K100700 | Med-Rx Pediatric Feeding Tubes and AccessoriesFPD · Traditional | Benlan, Inc. | 12/13/2010SE |
| K101214 | Guardian ConnectionFPD · Traditional | Maulin Medical, LLC | 07/23/2010SE |
| K100099 | Oral/Enteral SyringesFPD · Traditional | Philips Children'S Medical Ventures | 06/14/2010SE |
More from Philips Children'S Medical Ventures
| 510(k) | Device | Decision |
|---|---|---|
| K051480 | Enteral Feeding TubeBSS · Traditional | 10/12/2005SE |
| K970145 | Perineometer & Vaginal Probe (Biofeedback Monitor #20 and Vaginal Probe)HIR · Traditional | 08/11/1997SE |
| K964871 | Biosearch Syring Flushing/Cleaning Pump for Biosearch Endoscopic InstrumentsFEB · Traditional | 03/03/1997SE |
| K951260 | Urinary Intermittent Catheters W/O Hydromer Hydrophilic LubricantKOD · Traditional | 09/27/1995SE |
| K944614 | Mega-Brush, Endoscopic Mass Cytology - Celluar Retrieval SystemFDX · Traditional | 04/05/1995SE |
| K932295 | Non-Balloon Replacement Gastrostomy KitKNT · Traditional | 09/08/1994SE |
| K935045 | Biosearch Laproscopic Gastronomy CatheterKNT · Traditional | 08/19/1994SE |
| K923002 | Enteroclysis TubeKNT · Traditional | 06/28/1994SESK |
| K934193 | Cell-Mate(Tm) Mass Cytology-Cellular Retrieval SystEOX · Traditional | 11/19/1993SE |
| K922987 | Lapstick Laparoscopic Sponge Stick/ Blunt Dissec.GCJ · Traditional | 04/23/1993SE |
Questions and answers
When was Dobbhoff Enteric Feeding Bag cleared by the FDA?
Dobbhoff Enteric Feeding Bag (K781385) received a 510(k) decision of Substantially Equivalent on September 7, 1978, 27 days after the submission was received.
What is the product code of K781385?
The FDA product code is FPD – Tube, Feeding, a Class II (moderate risk) device regulated under 21 CFR 876.5980.