510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862853Substantially Equivalent for Some Indications

Syringe Injection Gun

Gastrotech, Inc., Independence OH / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K862853 is the FDA 510(k) clearance record for SYRINGE INJECTION GUN, cleared for Gastrotech, Inc. on . FDA records list 5 510(k) clearances for Gastrotech, Inc., from to . As of , FDA records show no recalls naming K862853.

Clearance record

Decision date
Received
(8 days to decision)
Review panel
Unknown
Applicant
Gastrotech, Inc. 6551 Brecksville Rd., Independence OH
Third party review
No