510(k) K971374
K971374 is an FDA 510(k) premarket notification submitted by Wilson Greatbatch Technologies, Inc. for the device "GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE". The FDA issued a decision of Substantially Equivalent on May 13, 1998. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Wilson Greatbatch Technologies, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 1998
- Date Received
- April 14, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hysteroscope (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1690
- Review Panel
- OB
- Submission Type