4 Sure TM Feeding Tubes
FDA 510(k) K921853 · Boston Pacific Medical, Inc.
510(k) numberK921853
Submission
- Device name
- 4 Sure TM Feeding Tubes
- Applicant
- Boston Pacific Medical, Inc.
Boston, MA, US - Received
- April 17, 1992
- Decision date
- July 13, 1993
- 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 |
|---|---|---|
| K933109 | 4SURE Uro-Link Urological Procedure TraysKOD · Traditional | 03/28/1994SEKD |
| K922402 | 4 Sure TM Enteral Feeding BagFPD · Traditional | 03/25/1994SE |
| K931048 | 4-SURE Nelaton CatheterEZD · Traditional | 02/14/1994SE |
| K931047 | 4-SURE Female CatheterEZD · Traditional | 02/14/1994SE |
| K921852 | 4 Sure TM Rectal TubeKMO · Traditional | 10/08/1993SE |
| K921851 | 4 Sure TM Suction Catheters & KitsBSY · Traditional | 07/07/1993SESK |
| K922398 | 4 Sure TM Enema Bag SetFCE · Traditional | 06/17/1993SEKD |
| K922397 | 4 Sure TM Nasal Oxygen CannulaCAT · Traditional | 03/18/1993SE |
| K924995 | 4 Sure TM Anesthesia Extension SetBSO · Traditional | 12/30/1992SE |
| K922401 | 4 Sure TM Colostomy PouchEZQ · Traditional | 06/10/1992SE |
Questions and answers
When was 4 Sure TM Feeding Tubes cleared by the FDA?
4 Sure TM Feeding Tubes (K921853) received a 510(k) decision of Substantially Equivalent on July 13, 1993, 452 days after the submission was received.
What is the product code of K921853?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.