FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CITATION MEDICAL SCOPE PROCEDURE PACK
K Number: K912490
·
Decision Aug 16, 1991
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
12
Review Days
73
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Basic Information
- Device Name
- CITATION MEDICAL SCOPE PROCEDURE PACK
- K Number
- K912490
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Citation Medical Corp.
- Date Received
- June 4, 1991
- Decision Date
- August 16, 1991
- Product Code
- KKX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Citation Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K951941 | CITATION MULTIPLE USE DELTA SCOPE | Jul 14, 1995 | Substantially Equivalent |
| K945390 | CITATION DELTA SCOPE | Jun 23, 1995 | Substantially Equivalent |
| K946290 | CITATION POWER TOOL | Jun 15, 1995 | Substantially Equivalent |
| K951249 | CITATION SINUSCOPE | Apr 10, 1995 | Substantially Equivalent |
| K944976 | BRONCHOSCOPE,NON-RIGID | Dec 21, 1994 | Substantially Equivalent |
| K940847 | ENDOSCOPIC PLANTAR FASCIA KIT | Oct 11, 1994 | Substantially Equivalent |
| K941563 | THE BIOPSY TOOL | Sep 26, 1994 | Substantially Equivalent |
| K924494 | CITSCOPE, BENDABLE -- MODIFICATION | May 26, 1993 | Substantially Equivalent for Some Indications |
| K922144 | CITSCOPE (MODEL EXTENSIONS) | Aug 5, 1992 | Substantially Equivalent |
| K921692 | INTEGRATED VIDEO SYSTEM | Jul 1, 1992 | Substantially Equivalent |