Oxy-Bloc
FDA 510(k) K931044 · Gi Supply
510(k) numberK931044
Submission
- Device name
- Oxy-Bloc
- Applicant
- Gi Supply
Camp Hill, PA, US - Received
- March 1, 1993
- Decision date
- October 4, 1993
- 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 |
| 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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| K944903 | Hp-FastLYR · Traditional | 04/20/1995SE |
| K915816 | Bite Block/Mouthpiece for EndoscopyEOQ · Traditional | 03/27/1992SE |
Questions and answers
When was Oxy-Bloc cleared by the FDA?
Oxy-Bloc (K931044) received a 510(k) decision of Substantially Equivalent on October 4, 1993, 217 days after the submission was received.
What is the product code of K931044?
The FDA product code is MNK – Endoscopic Bite Block, a Class I (low risk) device regulated under 21 CFR 876.1500.