510(k) K921963
K921963 is an FDA 510(k) premarket notification submitted by Sun Medical, Inc. for the device "DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900". The FDA issued a decision of Substantially Equivalent on Sep 11, 1992. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Sun Medical, Inc. has 3 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 11, 1992
- Date Received
- Apr 27, 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
- 510(k)