510(k) K051281
K051281 is an FDA 510(k) premarket notification submitted by E.D.Medical , Ltd. for the device "THE NEEDLE CATCHER". The FDA issued a decision of Substantially Equivalent on September 8, 2005. The device falls under product code HTD (Forceps), a Class I device regulated under 21 CFR 878.4800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 2005
- Date Received
- May 17, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type