510(k) K922154
K922154 is an FDA 510(k) premarket notification submitted by Olsen Electrosurgical, Inc. for the device "INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION". The FDA issued a decision of Substantially Equivalent on April 21, 1994. The device falls under product code HIB (Speculum, Vaginal, Nonmetal), a Class II device regulated under 21 CFR 884.4530. Olsen Electrosurgical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1994
- Date Received
- May 7, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Speculum, Vaginal, Nonmetal
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type