510(k) K926036
K926036 is an FDA 510(k) premarket notification submitted by Acufex Microsurgical, Inc. for the device "ACUFEX SUTURE RETRIEVER". The FDA issued a decision of Substantially Equivalent on May 5, 1993. The device falls under product code GAE (Snare, Surgical), a Class I device regulated under 21 CFR 878.4800. Acufex Microsurgical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 1993
- Date Received
- December 1, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Snare, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type