K070836 is the FDA 510(k) clearance record for EXICLIP EXCS-M, a class I device, cleared for Clevex, Inc. on 2007-04-20 under FDA product code MJG (Device, Percutaneous, Biopsy). FDA records list one 510(k) clearance for Clevex, Inc. As of 2026-09-10 , FDA records show no recalls naming K070836.
Clearance record Decision date 2007-04-20 Received 2007-03-27 (24 days to decision) Product code MJG Device, Percutaneous, BiopsyRegulation 21 CFR 878.4800 Device class Class I Review panel General, Plastic Surgery Applicant Clevex, Inc. 9996 Carrousel Ct., Loveland OH 510(k) summary Summary PDF ↗ Third party review No
Clearances, product code MJG Trailing 12 months FDA records hold no clearances under product code MJG in the trailing twelve months.
FDA records show no clearances under product code MJG in the twelve months to October 2026. Show the numbers FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
Product code MJG
Z-3058-2024 Class II Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage... MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-04-08 Z-1525-2024 Class II Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility Cook Incorporated / initiated 2024-03-01 / 6,178 units Z-2493-2021 Class II Sterility assurance may be compromised. M.D.L. S.r.l. / initiated 2021-08-05 / 4120 units Z-0025-2011 Medical Device Technologies, Inc., dba Angiotech, Gaineville, Florida is recalling Tru-Core II Disposable Biopsy Devices due to... Medical Device Technologies, Inc. / initiated 2010-07-02 / 11,123 boxes (111,230 units)
MDM coverage of this record lists here, newest first.
About this record Sourced from the FDA 510(k) premarket notification database, ingested from openFDA. MDM adds the decision time in days, the product code cross-link, recalls sharing that product code, and MDM coverage of the record.
Predicate devices are not listed. The openFDA 510(k) endpoint does not publish predicate references, so MDM does not assert them. Where a 510(k) summary exists, the FDA PDF is linked above and names the predicate itself.
Data as of 2026-09-28 , the FDA export date for this dataset. Page last changed 2026-09-05 . View this record on fda.gov ↗ (opens on fda.gov)
