510(k) K870194
K870194 is an FDA 510(k) premarket notification submitted by United Surgical Corp. for the device "UNITED SURGICAL CORP. DIATHERMIC PLUS". The FDA issued a decision of Substantially Equivalent on February 20, 1987. The device falls under product code HQR (Apparatus, Cautery, Radiofrequency, Ac-Powered), a Class II device regulated under 21 CFR 886.4100. United Surgical Corp. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 20, 1987
- Date Received
- January 20, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Cautery, Radiofrequency, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.4100
- Review Panel
- OP
- Submission Type