510(k) K881332
K881332 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "DIAFLEX GRASP FORCEPS/RETRIEVAL LOOP & CYTO BRUSH". The FDA issued a decision of Substantially Equivalent on Apr 27, 1988. The device falls under product code OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered), a Class II device regulated under 21 CFR 876.1500. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 27, 1988
- Date Received
- Mar 29, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Endoscopic Grasping/Cutting Instrument, Non-Powered
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
- 510(k)
To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.