510(k) K813332
K813332 is an FDA 510(k) premarket notification submitted by Inmed Corp. for the device "BRISTOL BALLON INTRODUCER, MANDRIL SET". The FDA issued a decision of Substantially Equivalent on December 14, 1981. The device falls under product code NWU (Endoscope Introducer Kit), a Class II device regulated under 21 CFR 876.1500. Inmed Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 1981
- Date Received
- November 24, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscope Introducer Kit
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.