510(k) K193339
K193339 is an FDA 510(k) premarket notification submitted by Guangzhou T.K Medical Instrument Co., Ltd. for the device "GTK Veress Needles". The FDA issued a decision of Substantially Equivalent on Jan 30, 2020. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Guangzhou T.K Medical Instrument Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 30, 2020
- Date Received
- Dec 2, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Insufflator, Laparoscopic
- Device Class
- Class II
- Regulation Number
- 884.1730
- Review Panel
- OB
- Submission Type
- 510(k)