510(k) K984239
K984239 is an FDA 510(k) premarket notification submitted by Aaron Medical Industries for the device "SLICKTIP SOLID LAPAROSCOPIC ELECTRODE, MODELS LH01Z, LB02Z, LN03Z, LC04Z, LS05Z, LL06Z, LJ07Z". The FDA issued a decision of Substantially Equivalent on February 10, 1999. The device falls under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories), a Class II device regulated under 21 CFR 878.4400. Aaron Medical Industries has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 1999
- Date Received
- November 27, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrosurgical, Cutting & Coagulation & Accessories
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).