510(k) K980972
K980972 is an FDA 510(k) premarket notification submitted by Circon Corp. for the device "RIGID CULDOSCOPE AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on June 12, 1998. The device falls under product code HEW (Culdoscope (And Accessories)), a Class II device regulated under 21 CFR 884.1640. Circon Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 12, 1998
- Date Received
- March 16, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culdoscope (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1640
- Review Panel
- OB
- Submission Type