FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OVERTUBE FOR ENDSCOPIC LIGATOR
K Number: K924764
·
Decision Mar 15, 1993
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
5
Applicant Total
14
Review Days
173
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Basic Information
- Device Name
- OVERTUBE FOR ENDSCOPIC LIGATOR
- K Number
- K924764
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Superior Healthcare Group, Inc.
- Date Received
- September 23, 1992
- Decision Date
- March 15, 1993
- Product Code
- MNK
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MNK | Endoscopic Bite Block | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MNK), ordered by most recent decision date.
OXYGEN MOUTHGUARD
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ENCOMPAS COMFORT BLOCK # 0B-10
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OXY-BLOC
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OXYGUARD
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
BITE BLOCK
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Other Clearances by Superior Healthcare Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K925530 | INSTRUMENT WARMER | Jun 18, 1993 | Substantially Equivalent |
| K905755 | NON-STERILE PATIENT EXAMINATION GLOVES | Mar 8, 1991 | Substantially Equivalent |
| K903347 | SODIUM CHLORIDE SOLUTION | Dec 13, 1990 | Substantially Equivalent |
| K904216 | STERILE WATER SOLUTION CATALOG # 10000 | Nov 16, 1990 | Substantially Equivalent |
| K903340 | STERILE URETHRAL CATHETER PROCEDURE KITS | Oct 4, 1990 | Unknown |
| K896321 | NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH. | Nov 13, 1989 | Substantially Equivalent |
| K894676 | STERILE LATEX EXAM GLOVES | Aug 17, 1989 | Substantially Equivalent |
| K891445 | LATEX EXAMINATION GLOVES | Aug 9, 1989 | Substantially Equivalent |
| K892426 | NO. 86500 - ENDOSCOPIC JET WASHER | Jun 22, 1989 | Substantially Equivalent |
| K885339 | FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT | Mar 1, 1989 | Substantially Equivalent |