510(k) K911272
K911272 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705". The FDA issued a decision of Substantially Equivalent on July 2, 1991. The device falls under product code FHG (Bell, Circumcision), a Class II device regulated under 21 CFR 884.4530. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 1991
- Date Received
- March 22, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bell, Circumcision
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type