510(k) K924196
K924196 is an FDA 510(k) premarket notification submitted by Nusurg, Inc. for the device "LAPAROSCOPIC NEEDLE HOLDER". The FDA issued a decision of Substantially Equivalent on Jun 25, 1993. The device falls under product code FHQ (Holder, Needle, Gastroenterologic), a Class I device regulated under 21 CFR 876.4730. Nusurg, Inc. has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 25, 1993
- Date Received
- Aug 20, 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
- 510(k) Exempt