FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GYNESURG
K Number: K780587
·
Decision May 25, 1978
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
57
Applicant Total
20
Review Days
44
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Basic Information
- Device Name
- GYNESURG
- K Number
- K780587
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Polamedco, Inc.
- Date Received
- April 11, 1978
- Decision Date
- May 25, 1978
- Product Code
- KNA
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNA), ordered by most recent decision date.
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GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER
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COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
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BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500
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EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01
FDA 510(k)
FDA Class 2
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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 |
| K933596 | GASTRIC, CATHETER, IRRIGATION & ASPIRATION | Feb 13, 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 |