Mic-Key Glow Profile Gastrostomy Replacement Kit
FDA 510(k) K982894 · Ballard Medical Products
510(k) numberK982894
Submission
- Device name
- Mic-Key Glow Profile Gastrostomy Replacement Kit
- Applicant
- Ballard Medical Products
Draper, UT, US - Received
- August 17, 1998
- Decision date
- September 11, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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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| 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 |
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| 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 |
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| K013892 | Lutz NeedleBSP · Traditional | 07/11/2002SE |
| K000495 | Ballard Medical Products Epidural and Spinal NeedlesBSP · Traditional | 03/28/2000SE |
| K993138 | Ballard Mic-Key G Low Profile Gastrostomy Replacement KitKNT · Special | 10/20/1999SE |
| K990376 | Ballard Medical Products Faciletome Bow String PapillotomeKNS · Traditional | 05/03/1999SE |
| K974630 | 72 Hour Use Trach Care with MicrobanCAH · Traditional | 03/11/1998SE |
| K964369 | Trach Care Set with MicrobanBSY · Traditional | 02/11/1997SE |
| K951533 | Easi-Lav Pediatric / Adult Gastric Lavage KitKDH · Traditional | 07/05/1995SE |
| K923487 | Bal CathKTR · Traditional | 07/30/1993SESK |
Questions and answers
When was Mic-Key Glow Profile Gastrostomy Replacement Kit cleared by the FDA?
Mic-Key Glow Profile Gastrostomy Replacement Kit (K982894) received a 510(k) decision of Substantially Equivalent on September 11, 1998, 25 days after the submission was received.
What is the product code of K982894?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.