510(k) · Cleared

Cleared

Vanguard Reprocessed Electric Biopsy Forceps

K011800510(k) TraditionalCleared Sep 27, 2001111-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

Vanguard Medical Concepts, Inc. · NLU Forceps, Biopsy, Electric, Reprocessed

Cleared on Sep 27, 2001 as substantially equivalent to K860366 (Microvasive, 1986) and 1 other predicate after a 111-day review. Its family tree reaches back 1 generation to 1986.

Decided: Sep 27, 2001
Review: 111 days
Class: Class II
Product code: NLU
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K860366 (1986). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK860366 Challenger Hot Biopsy ForcepsMicrovasive · 1986
This deviceK011800 Vanguard Reprocessed Electric Biopsy ForcepsVanguard Medical Concepts, Inc. · 2001

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K860366	Challenger Hot Biopsy Forceps	Microvasive	1986	—
0 (this device)	K011800	Vanguard Reprocessed Electric Biopsy Forceps	Vanguard Medical Concepts, Inc.	2001	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0

FIG. 1 — Lineage of K011800, 1986–2001Source: 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? (2)

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
*	K860366	Challenger Hot Biopsy Forceps Summary page 5 …ct Code KGE Predicate e Boston Scientific Microvasive® Radial Jaw® 3 Electric Biopsy Forceps Devices believed to be legally marketed under 510(k) premarket notification K860366 e C.R. Bard Precisor® Hot Biopsy Forceps believed to be legally marketed under 510(k) premarket notification K912601 Indication…	Microvasive	1986	—
*	K912601	Biprobe (TM) Summary page 5 …egally marketed under 510(k) premarket notification K860366 e C.R. Bard Precisor® Hot Biopsy Forceps believed to be legally marketed under 510(k) premarket notification K912601 Indications for When used with a compatible electrosurgical unit, endoscope and patient Use grounding pad, electric biopsy for…	C.R. Bard, Inc.	1991	—

Also cleared against K860366: 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?

None of the 2 ancestors has a recall.
1 other device also cites its predicate K860366.

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?

When used with a compatible electrosurgical unit, endoscope and patient grounding pad, electric biopsy forceps are intended for electrocautery and removal of polyps and/or tissue within the gastrointestinal tract. The forceps are prescription devices intended for a single patient use only.

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/K011800 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011800: Vanguard Reprocessed Electric 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/K011800

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026