510(k) K981579
K981579 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG". The FDA issued a decision of Substantially Equivalent on July 9, 1998. The device falls under product code MDM (Instrument, Manual, Surgical, General Use), a Class I device regulated under 21 CFR 878.4800. ETHICON, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 1998
- Date Received
- May 4, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Manual, Surgical, General Use
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type