510(k) K171001
K171001 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "Monosyn Quick Synthetic Absorbable Surgical Suture". The FDA issued a decision of Substantially Equivalent on Oct 23, 2017. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Aesculap, Inc. has 217 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 23, 2017
- Date Received
- Apr 4, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Absorbable, Synthetic, Polyglycolic Acid
- Device Class
- Class II
- Regulation Number
- 878.4493
- Review Panel
- SU
- Submission Type
- 510(k)