510(k) K913979
K913979 is an FDA 510(k) premarket notification submitted by Snowden-Pencer for the device "ENDO I/A Y SET". The FDA issued a decision of Substantially Equivalent on November 27, 1991. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Snowden-Pencer has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 27, 1991
- Date Received
- September 6, 1991
- 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