Overtube for Endscopic Ligator
FDA 510(k) K924764 · Superior Healthcare Group, Inc.
510(k) numberK924764
Submission
- Device name
- Overtube for Endscopic Ligator
- Applicant
- Superior Healthcare Group, Inc.
Cumberland, RI, US - Received
- September 23, 1992
- Decision date
- March 15, 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 |
| K931044 | Oxy-BlocMNK · Traditional | Gi Supply | 10/04/1993SE |
| K914978 | OxyguardMNK · Traditional | Stantex Pty , Ltd. | 01/10/1992SE |
| K896691 | Bite BlockMNK · Traditional | Endoscopix | 02/12/1990SE |
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| K891445 | Latex Examination GlovesLYY · Traditional | 08/09/1989SE |
| K892426 | No. 86500 - Endoscopic Jet WasherOCX · Traditional | 06/22/1989SE |
| K885339 | Flow Thru 16,18,20,22 FR Replace. Gastro Tube KitKNT · Traditional | 03/01/1989SE |
Questions and answers
When was Overtube for Endscopic Ligator cleared by the FDA?
Overtube for Endscopic Ligator (K924764) received a 510(k) decision of Substantially Equivalent on March 15, 1993, 173 days after the submission was received.
What is the product code of K924764?
The FDA product code is MNK – Endoscopic Bite Block, a Class I (low risk) device regulated under 21 CFR 876.1500.