510(k) K943624
K943624 is an FDA 510(k) premarket notification submitted by Henke-Sass, Wolf GmbH for the device "ELMED PNEUMOPERITONEUM NEEDLES". The FDA issued a decision of Substantially Equivalent on August 10, 1994. The device falls under product code FHO (Pneumoperitoneum Needle), a Class II device regulated under 21 CFR 876.1500. Henke-Sass, Wolf GmbH has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 1994
- Date Received
- July 26, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pneumoperitoneum Needle
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
For establishment of a pneumoperitoneum in abdomen.