FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
GESCO CATHETERIZATION TRAY
K Number: K882647
·
Decision Sep 9, 1988
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
7
Applicant Total
26
Review Days
74
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Basic Information
- Device Name
- GESCO CATHETERIZATION TRAY
- K Number
- K882647
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Applicant
- Gesco Intl., Inc.
- Date Received
- June 27, 1988
- Decision Date
- September 9, 1988
- Product Code
- GBQ
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GBQ | Catheter, Continuous Irrigation | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GBQ), ordered by most recent decision date.
MICROFLOW IRRIGATION SYSTEM
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CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT
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MODIFIED CURLCATH
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GASTRIC LAVAGE KIT-DISPOSABLE
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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 |
| K926063 | PER-Q-CATH DRESSING CHANGE TRAY | Jun 7, 1993 | Unknown |
| K923591 | PALA-NATE | Mar 16, 1993 | Substantially Equivalent |