510(k) · Cleared

Cleared

Reprocessed Single Use Devices Biopsy Forceps

K033593510(k) TraditionalCleared Nov 20, 20037-day reviewClass II21 CFR 876.4300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Clearmedical, Inc. · NLU Forceps, Biopsy, Electric, Reprocessed

Cleared on Nov 20, 2003 as substantially equivalent to K932266 (Symbiosis Corp., 1994) after a 7-day review. Its family tree reaches back 1 generation to 1994.

Decided: Nov 20, 2003
Review: 7 days
Class: Class II
Product code: NLU
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K932266 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK932266 Symbiosis Dispos Gastro Biopsy Forceps W/Reuse HanSymbiosis Corp. · 1994
This deviceK033593 Reprocessed Single Use Devices Biopsy ForcepsClearmedical, Inc. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K932266	Symbiosis Dispos Gastro Biopsy Forceps W/Reuse Han	Symbiosis Corp.	1994	—
0 (this device)	K033593	Reprocessed Single Use Devices Biopsy Forceps	Clearmedical, Inc.	2003	—

FIG. 1 — Lineage of K033593, 1994–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NLU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K932266	Symbiosis Dispos Gastro Biopsy Forceps W/Reuse Han Summary page 1 …. Clear Medical Reprocessed Used Disposable Biopsy Forceps are substantially equivalent to disposable biopsy forceps currently marketed new by Microvasive under 5 1O(k) 932266. “o" ‘“"c"'o" 3"' DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service b Food and Drug Administration 920…	Symbiosis Corp.	1994	—

Also cleared against K932266: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
1 other device also cites its predicate K932266.

How does its category compare?

All NLU devices

NLU Forceps, Biopsy, Electric, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NLU

FDA has decided no NLU device since 2007.

Median 510(k) review, days · NLU

Too few NLU 510(k)s in any year since 2007 to give a median.

Recalls per year · NLU

1in 2008

2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NLU

1in 2018

2007high 1 (2010) · low 0 (2007)2025

MAUDE reports naming product code NLU, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	1	0
2009	—	0	0
2010	—	0	1
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	1
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

What is it indicated for?

CMI intends to reprocess used disposable hot and cold biopsy forceps manufactured by Micovasive.

Cold biopsy forceps are intended to be used through an endoscope to remove polyps and/or tissue specimens throughout the alimentary tract

Hot Biopsy Forceps are intended to be used through an endoscope to cauterize and remove polyps and/or tissue specimens throughout the alimentary tract.

.CMI reprocessed biopsy forceps are disposable unless reprocessed again by Clear Medical,_ Inc.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K033593 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033593: Reprocessed Single Use Devices Biopsy Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033593

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026