FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
PER-Q-CATH DRESSING CHANGE TRAY
K Number: K926063
·
Decision Jun 7, 1993
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
23
Applicant Total
26
Review Days
188
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Basic Information
- Device Name
- PER-Q-CATH DRESSING CHANGE TRAY
- K Number
- K926063
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5075
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Gesco Intl., Inc.
- Date Received
- December 1, 1992
- Decision Date
- June 7, 1993
- Product Code
- MCY
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| MCY | Wound Dressing Kit | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MCY), ordered by most recent decision date.
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CIRCULON SYSTEM STEP 1
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CIRCULON SYSTEM STEP 2
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Other Clearances by Gesco Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954422 | PER-Q-CATH MID-LINE | Dec 15, 1995 | Substantially Equivalent |
| K940953 | UMBILI-CATH-S | Aug 2, 1994 | Substantially Equivalent |
| K940870 | UMBILI-CATH | Aug 2, 1994 | Substantially Equivalent |
| K940952 | UMBILI-CATH-S-DL | Jul 29, 1994 | Substantially Equivalent |
| K941672 | URI-CATH CATHETER | May 16, 1994 | Substantially Equivalent |
| K941232 | THORA-CATH | May 11, 1994 | Substantially Equivalent |
| K940871 | UMBILI-CATH-P | Apr 29, 1994 | Substantially Equivalent |
| K931989 | VENTRI-CATH | Jul 21, 1993 | Substantially Equivalent |
| K923591 | PALA-NATE | Mar 16, 1993 | Substantially Equivalent |
| K915167 | GESCO PER-Q-CATH CATHETER INTRODUCER | Jan 27, 1992 | Substantially Equivalent |