510(k) K010053
K010053 is an FDA 510(k) premarket notification submitted by Northgate Technologies, Inc. for the device "HUMI-FLOW, MODEL 6-850-00/ 01/02". The FDA issued a decision of Substantially Equivalent on October 23, 2001. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Northgate Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 2001
- Date Received
- January 8, 2001
- 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