510(k) K922244
K922244 is an FDA 510(k) premarket notification submitted by O.R. Concepts, Inc. for the device "INSUFFLATOR TUBING/FILTER KIT". The FDA issued a decision of Substantially Equivalent on September 24, 1993. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. O.R. Concepts, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 24, 1993
- Date Received
- May 13, 1992
- 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