510(k) · Cleared

Cleared

Flexible Fiberscopes & Accessories

K990397510(k) TraditionalCleared Oct 25, 1999258-day reviewClass II21 CFR 888.1100

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

Richard Wolf Medical Instruments Corp. · HRX Arthroscope

Cleared on Oct 25, 1999 as substantially equivalent to K962172 (Richard Wolf Medical Instruments Corp., 1996) and 2 other predicates after a 258-day review. Its family tree reaches back 1 generation to 1995.

Decided: Oct 25, 1999
Review: 258 days
Class: Class II
Product code: HRX
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K946087 (1995). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK946087 Inclusice II (TM) EndoscopeSofamor Danek USA,Inc. · 1995
This deviceK990397 Flexible Fiberscopes & AccessoriesRichard Wolf Medical Instruments Corp. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K946087	Inclusice II (TM) Endoscope	Sofamor Danek USA,Inc.	1995	—
0 (this device)	K990397	Flexible Fiberscopes & Accessories	Richard Wolf Medical Instruments Corp.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	1	0

FIG. 1 — Lineage of K990397, 1995–1999Source: 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 HRX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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#1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
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What was it cleared against? (4)

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
*	K962172	Flexible Mini-Fiberscopes Summary page 6 …e: F lexxb]e ﬁberscopes F lexlblc cndoscopes Informatmn on dewces to whlch substanhal eqmvalence is cla 510(k) Number Trade or proprietary or model name Manufacturer 1 K962172 1 Flexible Mini-Fiberscopes I Richard Wolf 2 2 LASE Flexible Endoscope 2 Clarus 3 K971455 3 SITEprobe diagnostic spinal endoscope…	Richard Wolf Medical Instruments Corp.	1996	—
*	K971455	Clarus Model 5197 Sightlite Summary page 6 …valence is cla 510(k) Number Trade or proprietary or model name Manufacturer 1 K962172 1 Flexible Mini-Fiberscopes I Richard Wolf 2 2 LASE Flexible Endoscope 2 Clarus 3 K971455 3 SITEprobe diagnostic spinal endoscope 3 Clarus 4 K946087 4 The Inclusive™ Endoscope System 4 Sofamor Danek 1.0 Description T…	Clarus Medical Systems, Inc.	1997	—
*	K946087	Inclusice II (TM) Endoscope Summary page 6 …name Manufacturer 1 K962172 1 Flexible Mini-Fiberscopes I Richard Wolf 2 2 LASE Flexible Endoscope 2 Clarus 3 K971455 3 SITEprobe diagnostic spinal endoscope 3 Clarus 4 K946087 4 The Inclusive™ Endoscope System 4 Sofamor Danek 1.0 Description The flexible endoscope consists of an eyepiece, with a focus…	Sofamor Danek USA,Inc.	1995	—
*	—	LASE Flexible Endoscope Named without a submission number			—

Also cleared against K962172: 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 3 ancestors has a recall.
1 other device also cites its predicate K962172.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRX

9in 2025

2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007high 249 (2023) · low 45 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRX

1in 2024

2007high 23 (2009) · low 0 (2012)2026

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

Adverse event reports per year · HRX

2,076in 2025

2007high 2,427 (2024) · low 421 (2007)2025

MAUDE reports naming product code HRX, 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	7	89	3	421
2008	9	115	13	441
2009	11	139	23	558
2010	9	114	12	612
2011	3	84	6	631
2012	11	102	0	778
2013	12	90	4	678
2014	9	140	0	802
2015	4	132	7	763
2016	8	89	0	469
2017	4	97	0	934
2018	12	101	1	1,581
2019	12	45	0	1,676
2020	7	141	0	1,706
2021	7	57	3	1,908
2022	3	89	0	1,406
2023	4	249	0	1,852
2024	6	110	1	2,427
2025	9	107	0	2,076
2026	7	217	0	—

What is it indicated for?

Flexible Fiberscope: For examination, diagnosis, and/or therapy in connection with endoscopic accessories and auxiliary instruments used through the working channel of the instrument for use in lumbar spine applications.

Flexible Biopsy Forcep: Used to obtain small biopsies from tissue

Electrodes: Used for unipolar coagulation.

Field of Application:

The instruments are designed to be used by adequately trained and qualified medical personnel in the fields of spine, urology, surgery, gynecology, and ENT.

IMPORTANT! The product dimensions must correspond with the anatomic proportions, ie; the correct flexible fiberscope must be selected for the medical procedure.

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/K990397 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990397: Flexible Fiberscopes & Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990397

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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