FDA product code OCZ: Endoscopic Grasping/Cutting Instrument, Non-Powered
OCZ is the FDA product code for endoscopic grasping/cutting instrument, non-powered. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 74 510(k) submissions under OCZ, 2 in the last five years, from 44 different applicants. The average 510(k) review took 80 days (median 77); 180 days on average over the last three years. FDA has posted 21 recalls for OCZ devices, 18 initiated in the last five years.
Definition
To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Grasping/Cutting Instrument, Non-Powered |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for OCZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 255 |
| 2024 | 1 | 87 |
| 2026 | 1 | 273 |
Compare with all 510(k) review times · Search every OCZ clearance
Top OCZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Endovations | 14 | 1987-12-29 |
| Mr Associates, Inc. | 6 | 1980-05-08 |
| Olympus America, Inc. | 4 | 1996-07-18 |
| Hobbs Medical, Inc. | 3 | 1985-01-03 |
| Slater Endoscopy, LLC | 2 | 2015-06-08 |
39 more applicants have OCZ clearances. See the full list in Caduvo.
Most recent OCZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252800 | Karl Storz SE & CO. KG | KARL STORZ Endoscopic Accessories for Urology | 2026-06-03 | 273 |
| K242923 | Envision Endoscopy | SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) | 2024-12-20 | 87 |
| K191900 | Zhejiang Chuangxiang Medical Technology Co., Ltd. | Single Use Grasping Forceps | 2020-03-27 | 255 |
| K152802 | Micro-Tech (Nanjing) Co., Ltd. | Grasping Forceps | 2016-01-21 | 115 |
| K150939 | Slater Endoscopy, LLC | Ensizor Endoscopic Scissors | 2015-06-08 | 62 |
Recalls for OCZ devices
21 product recalls in 4 recall events; 18 initiated in the last five years and 18 still open. Most recent: 2022-07-29.
| Year | Recalls |
|---|---|
| 2021 | 2 |
| 2022 | 18 |
Frequently asked questions
What is FDA product code OCZ?
OCZ is the FDA product code for endoscopic grasping/cutting instrument, non-powered. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is OCZ?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code OCZ?
Across 74 cleared submissions the average was 80 days from receipt to decision (median 77).
Which companies have the most OCZ clearances?
Endovations (14); Mr Associates, Inc. (6); Olympus America, Inc. (4); Hobbs Medical, Inc. (3); Slater Endoscopy, LLC (2).
Have OCZ devices been recalled?
Yes: 21 product recalls across 4 recall events; the most recent began 2022-07-29.
Next steps
- Run an FDA pathway report with predicate devices for product code OCZ
- Run a recall and safety report across every OCZ manufacturer
- Watch product code OCZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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