Trip Tonometry Catheter, 14F
FDA 510(k) K993296 · Datex-Ohmeda, Inc.
510(k) numberK993296
Submission
- Device name
- Trip Tonometry Catheter, 14F
- Applicant
- Datex-Ohmeda, Inc.
Tewksburt, MA, US - Received
- October 1, 1999
- Decision date
- December 15, 1999
- Decision
- Substantially Equivalent (SESE)
- 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
Other 510(k)s with product code KNT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K254036 | Novii+ Wireless Patch SystemHGM · Traditional | 08/10/2026SE |
| K260326 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)FMZ · Traditional | 07/28/2026SE |
| K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)FMZ · Traditional | 10/22/2025SE |
| K231964 | Novii+ Wireless Patch SystemHGM · Traditional | 12/08/2023SE |
| K213867 | Carestation 750/750cBSZ · Traditional | 03/28/2023SE |
| K213553 | Giraffe Incubator Carestation CS1FMZ · Traditional | 03/02/2022SE |
| K213551 | Giraffe Omnibed Carestation CS1FMT · Traditional | 03/02/2022SE |
| K210384 | Carescape R860CBK · Traditional | 11/04/2021SE |
| K172702 | Tec 820, Tec 850CAD · Traditional | 01/04/2018SE |
| K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…BSZ · Traditional | 11/03/2017SE |
Questions and answers
When was Trip Tonometry Catheter, 14F cleared by the FDA?
Trip Tonometry Catheter, 14F (K993296) received a 510(k) decision of Substantially Equivalent on December 15, 1999, 75 days after the submission was received.
What is the product code of K993296?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.