FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GASTRIC, CATHETER, IRRIGATION & ASPIRATION
K Number: K933596
·
Decision Feb 13, 1995
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
12
Applicant Total
20
Review Days
567
Basic Information
- Device Name
- GASTRIC, CATHETER, IRRIGATION & ASPIRATION
- K Number
- K933596
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- POLAMEDCO, INC.
- Date Received
- July 26, 1993
- Decision Date
- February 13, 1995
- Product Code
- BSS
- 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 |
|---|---|---|---|
| BSS | Tube, Nasogastric | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by POLAMEDCO, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K983000 | CRICOTHYROTOMY TUBE | Oct 27, 1999 | Substantially Equivalent |
| K954383 | SURELOC CIRCUIT CONNECTOR | Dec 22, 1995 | Substantially Equivalent |
| K953793 | INTROSCOPE | Nov 29, 1995 | Substantially Equivalent |
| K950713 | AIRGUIDE STYLETTE | May 17, 1995 | Substantially Equivalent |
| K950380 | FLEXTITIP STYLETTE | Feb 10, 1995 | Substantially Equivalent |
| K920900 | POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES | Mar 18, 1992 | Substantially Equivalent |
| K900456 | POLAMEDCO NASOPAHARYNGEAL AIRWAY | Apr 19, 1990 | Substantially Equivalent |
| K900457 | CUFFED LINDER NASOTRACHEAL AIRWAY | Apr 16, 1990 | Substantially Equivalent |
| K894516 | VISOSHIELD(TM), SURGICAL EYE PROTECTOR | Sep 12, 1989 | Substantially Equivalent |
| K881496 | LINDER NASOTRACHEAL AIRWAY | May 31, 1988 | Substantially Equivalent |