510(k) K873248
K873248 is an FDA 510(k) premarket notification submitted by Medical Engineering Laboratory, Inc. for the device "GASTROINTESTINAL FLEXIBLE BIOSPY FORCEPS". The FDA issued a decision of Substantially Equivalent on December 30, 1987. The device falls under product code OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered), a Class II device regulated under 21 CFR 876.1500. Medical Engineering Laboratory, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 1987
- Date Received
- August 14, 1987
- 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
To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.