510(k) K854916
K854916 is an FDA 510(k) premarket notification submitted by Pilling Co. for the device "PILLING HEMOSTATIC CLIP APPLIER FORCEPS". The FDA issued a decision of Substantially Equivalent on January 24, 1986. The device falls under product code GEN (Forceps, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Pilling Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 24, 1986
- Date Received
- December 9, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type