Enteroclysis Tube
FDA 510(k) K923002 · Biosearch Medical Products, Inc.
510(k) numberK923002
Submission
- Device name
- Enteroclysis Tube
- Applicant
- Biosearch Medical Products, Inc.
Somerville, NJ, US - Received
- June 22, 1992
- Decision date
- June 28, 1994
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KNT – Tubes, Gastrointestinal (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
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|---|---|---|---|
| K261890 | 52Fr ViSiGi LUX; 52Fr ViSiGi 3D®KNT · Special | Boehringer Laboratories, LLC | 08/14/2026SE |
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional | C.R. Bard, Inc. | 07/10/2026SE |
| K250389 | XNY Disposable Gastric Calibration TubeKNT · Traditional | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 04/10/2025SE |
| K243228 | Flexi-Seal AIR (with ENFit Connector)KNT · Traditional | Convatec | 03/28/2025SE |
| K242336 | hygh-tec Drainage IIKNT · Traditional | Amb Medtec | 01/17/2025SE |
| K242901 | ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT…KNT · Traditional | Tools For Surgery, LLC | 01/10/2025SE |
| K241169 | Entarik NI Feeding Tube SystemKNT · Traditional | Gravitas Medical, Inc. | 11/22/2024SE |
| K241185 | CORGRIP* SR NG/NI Tube Retention SystemKNT · Traditional | Avanos Medical, Inc. | 10/25/2024SE |
| K240965 | CORTRAK* 2 Enteral Access System (20-0950)KNT · Traditional | Avanos Medical, Inc. | 06/06/2024SE |
| K233591 | StylusKNT · Traditional | Degania Silicone , Ltd. | 05/31/2024SE |
More from Degania Silicone , Ltd.
| 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 |
| 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 |
| K923474 | Low Profile Gastromstomy DeviceKNT · Traditional | 01/05/1993SESK |
Questions and answers
When was Enteroclysis Tube cleared by the FDA?
Enteroclysis Tube (K923002) received a 510(k) decision of Unknown on June 28, 1994, 736 days after the submission was received.
What is the product code of K923002?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.