510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OCZClass II

Endoscopic Grasping/Cutting Instrument, Non-Powered

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

OCZ is the FDA product code for Endoscopic Grasping/Cutting Instrument, Non-Powered, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope". As of , FDA records hold 74 510(k) clearances under this code, the most recent dated , and 21 recalls.

Classification record

Product code
OCZ
Device name
Endoscopic Grasping/Cutting Instrument, Non-Powered
FDA definition
To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
74
Ingested recalls
21

Clearances, product code OCZ

By decision year
74 clearances under product code OCZ with a decision year between 1976 and 2026, 1987 the highest year at 18.
Show the numbers
510(k) clearances under FDA product code OCZ by decision year
YearClearances
19761
19791
19806
19821
19833
19841
19852
198718
19882
19892
19903
19911
19922
19931
19943
19952
19964
19977
20012
20051
20081
20101
20111
20121
20142
20151
20161
20201
20241
20261

Applicants with the most clearances

Product code OCZ
Applicants holding the most 510(k) clearances under product code OCZ
ApplicantClearances
Endovations14
Mr Associates, Inc.6
OLYMPUS Corporation of the Americas4
Hobbs Medical, Inc.3
Cook Incorporated2
Cox Medical Ent., Inc.2
Boston Scientific Corporation2
Medical Engineering Laboratory, Inc.2
Slater Endoscopy, LLC2
TeleMed Systems2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 44 companies shown, in name order