FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION
K Number: K922154
·
Decision Apr 21, 1994
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
71
Applicant Total
11
Review Days
714
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Basic Information
- Device Name
- INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION
- K Number
- K922154
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Olsen Electrosurgical, Inc.
- Date Received
- May 7, 1992
- Decision Date
- April 21, 1994
- Product Code
- HIB
- 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 |
|---|---|---|---|
| HIB | Speculum, Vaginal, Nonmetal | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Olsen Electrosurgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K912611 | OLSEN LAPAROSCOPIC INSTR, DISPOSABLE, SINGLE USE | Apr 15, 1992 | Substantially Equivalent |
| K913108 | TEFLON COATED ELECTRODES/ELECTRODES HANDLES | Dec 23, 1991 | Substantially Equivalent |
| K912612 | SMOKE/ODOR EVACUATOR #757 | Nov 1, 1991 | Substantially Equivalent |
| K885200 | 600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE | Jan 13, 1989 | Substantially Equivalent |
| K885199 | #500 SERIES FORCEPS W/CUT/COAGULATE SWITCHES | Jan 13, 1989 | Substantially Equivalent |
| K884171 | #875 DISPOSABLE BIOPOLAR CABLE | Oct 24, 1988 | Substantially Equivalent |
| K884173 | #920 DISPOSABLE TUR CABLE | Oct 24, 1988 | Substantially Equivalent |
| K884174 | MODIFIED OLSEN 755/756 SWITCHPENS | Oct 24, 1988 | Substantially Equivalent |
| K884175 | #820/821 BIPOLAR FORCEPS | Oct 24, 1988 | Substantially Equivalent |
| K884172 | MODIFIED OLSEN #770 DISPOSABLE HOLSTER | Oct 24, 1988 | Substantially Equivalent |