Oxyguard
FDA 510(k) K914978 · Stantex Pty , Ltd.
510(k) numberK914978
Submission
- Device name
- Oxyguard
- Applicant
- Stantex Pty , Ltd.
Sydney, New South Wales, AU - Received
- November 6, 1991
- Decision date
- January 10, 1992
- 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 |
|---|---|---|---|
| K944049 | Oxygen MouthguardMNK · Traditional | Endovations, Inc. | 10/11/1994SE |
| 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 |
| K896691 | Bite BlockMNK · Traditional | Endoscopix | 02/12/1990SE |
Questions and answers
When was Oxyguard cleared by the FDA?
Oxyguard (K914978) received a 510(k) decision of Substantially Equivalent on January 10, 1992, 65 days after the submission was received.
What is the product code of K914978?
The FDA product code is MNK – Endoscopic Bite Block, a Class I (low risk) device regulated under 21 CFR 876.1500.