510(k) K900878
K900878 is an FDA 510(k) premarket notification submitted by Gynescope Corp. for the device "OTT INSUFFLATION FILTER TUBING". The FDA issued a decision of Substantially Equivalent on May 7, 1990. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Gynescope Corp. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 7, 1990
- Date Received
- February 26, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Insufflator, Laparoscopic
- Device Class
- Class II
- Regulation Number
- 884.1730
- Review Panel
- OB
- Submission Type