510(k) · Cleared
Recalled · Class II · 2021Telemed Systems Retrieval Basket
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Telemed Systems, Inc. · OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered
Cleared on Dec 19, 1997 after a 32-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 2 times.
- Decided
- Dec 19, 1997
- Review
- 32 days
- Class
- Class II
- Product code
- OCZ
- Recalls
- 2
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OCZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OCZ device
- #1 K252800 KARL STORZ Endoscopic Accessories for Urologyscore 11.4 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 12, 2021 | Class II | Z-2230-2021 | Packaging process control | Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm) may actually be catalog #7226 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 8 mm x 230 cm) and Devices labeled as catalog #7226… |
| Jan 12, 2021 | Class II | Z-2229-2021 | Packaging process control | Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm) may actually be catalog #7226 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 8 mm x 230 cm) and Devices labeled as catalog #7226… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All OCZ devicesOCZ Endoscopic Grasping/Cutting Instrument, Non-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OCZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OCZ
Too few OCZ 510(k)s in any year since 2007 to give a median.
Recalls per year · OCZ
17in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCZ
34in 2025
MAUDE reports naming product code OCZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 242 |
| 2016 | 1 | — | 0 | 759 |
| 2017 | 0 | — | 0 | 734 |
| 2018 | 0 | — | 0 | 252 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 21 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 17 | 33 |
| 2023 | 0 | — | 0 | 25 |
| 2024 | 1 | — | 0 | 37 |
| 2025 | 0 | — | 0 | 34 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The TeleMed System Retrieval Basket is indicated for use in the endoscopic removal of loose bodies, stones or parts of [unreadable in OCR].
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974300: Telemed Systems Retrieval Basket.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974300
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026