Oxygen Mouthguard
FDA 510(k) K944049 · Endovations, Inc.
510(k) numberK944049
Submission
- Device name
- Oxygen Mouthguard
- Applicant
- Endovations, Inc.
Reading, PA, US - Received
- August 18, 1994
- Decision date
- October 11, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MNK – Endoscopic Bite Block
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To prevent patient from biting down in order to protect fragile endoscope equipment, patient's teeth and gums, and endscopist's fingers when inserting endoscope orally.
Other 510(k)s with product code MNK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933537 | Encompas Comfort Block # 0B-10MNK · Traditional | Encompas Unlimited, Inc. | 04/08/1994SE |
| K931044 | Oxy-BlocMNK · Traditional | Gi Supply | 10/04/1993SE |
| K924764 | Overtube for Endscopic LigatorMNK · Traditional | Superior Healthcare Group, Inc. | 03/15/1993SE |
| K914978 | OxyguardMNK · Traditional | Stantex Pty , Ltd. | 01/10/1992SE |
| K896691 | Bite BlockMNK · Traditional | Endoscopix | 02/12/1990SE |
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| K913841 | 2 Lumen Endos Retro Cholangiopancrea Injec CathFGE · Traditional | 10/08/1991SE |
| K913870 | 5MM MicroscissorsGCJ · Traditional | 09/16/1991SE |
| K911155 | Oval Cup Biopsy ForcepFCF · Traditional | 08/07/1991SE |
| K892218 | Endo-SpongeMNL · Traditional | 05/31/1989SE |
| K883093 | Transendoscopic Aspiration NeedleFBK · Traditional | 12/08/1988SE |
| K873360 | Enteron Percutan. Endoscopic Gastrostomy Tray-PegKNT · Traditional | 03/30/1988SE |
| K875264 | Washing CatheterOCX · Traditional | 03/29/1988SE |
Questions and answers
When was Oxygen Mouthguard cleared by the FDA?
Oxygen Mouthguard (K944049) received a 510(k) decision of Substantially Equivalent on October 11, 1994, 54 days after the submission was received.
What is the product code of K944049?
The FDA product code is MNK – Endoscopic Bite Block, a Class I (low risk) device regulated under 21 CFR 876.1500.