510(k) K920706
K920706 is an FDA 510(k) premarket notification submitted by Retrax for the device "MAGNETIC POINT GUARD FOR SURGICAL NEEDLES". The FDA issued a decision of Substantially Equivalent on May 26, 1993. The device falls under product code FHQ (Holder, Needle, Gastroenterologic), a Class I device regulated under 21 CFR 876.4730. Retrax has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 1993
- Date Received
- February 18, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Holder, Needle, Gastroenterologic
- Device Class
- Class I
- Regulation Number
- 876.4730
- Review Panel
- GU
- Submission Type