Feeding Tube Placement Stylet
FDA 510(k) K792468 · Biosearch Medical Products, Inc.
510(k) numberK792468
Submission
- Device name
- Feeding Tube Placement Stylet
- Applicant
- Biosearch Medical Products, Inc.
Walker, MI, US - Received
- December 3, 1979
- Decision date
- December 27, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FZX – Guide, Surgical, Instrument
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FZX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K914715 | Paralleling GuidesFZX · Traditional | Implant Corp. of America | 02/16/1994SE |
| K871413 | Civco StepperFZX · Traditional | CIVCO Medical Instruments Co., Inc. | 07/14/1987SE |
| K871503 | Biopsy Needle Guide Kit, SterileFZX · Traditional | Amedic USA | 07/10/1987SE |
| K862564 | A.C.L. Guide KitFZX · Traditional | Aspen Laboratories, Inc. | 08/18/1986SE |
| K854262 | Meadox Surgimed Breast Localization Wire Set/OnlyFZX · Traditional | Meadox Surgimed, Inc. | 12/24/1985SE |
| K852402 | Namic Homer Mammalok Needle/Wire LocalizerFZX · Traditional | North American Instrument Corp. | 07/11/1985SE |
| K842698 | British Spinal Fusion SetFZX · Traditional | Downs Surgical , Ltd. | 09/12/1984SE |
| K841618 | Threading TubeFZX · Traditional | Plastafil, Inc. | 08/27/1984SE |
| K841619 | Drill GuideFZX · Traditional | Plastafil, Inc. | 07/11/1984SE |
| K841297 | Techmedica Drill GuideFZX · Traditional | Techmedica, Inc. | 04/25/1984SE |
More from Techmedica, Inc.
| 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 Feeding Tube Placement Stylet cleared by the FDA?
Feeding Tube Placement Stylet (K792468) received a 510(k) decision of Substantially Equivalent on December 27, 1979, 24 days after the submission was received.
What is the product code of K792468?
The FDA product code is FZX – Guide, Surgical, Instrument, a Class I (low risk) device regulated under 21 CFR 878.4800.