510(k) K900487
K900487 is an FDA 510(k) premarket notification submitted by United States Surgical, A Division of Tyco Healthc for the device "MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVE". The FDA issued a decision of Substantially Equivalent on February 9, 1990. The device falls under product code GDH (Gouge, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. United States Surgical, A Division of Tyco Healthc has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 1990
- Date Received
- January 23, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gouge, Surgical, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type