510(k) · Cleared

Cleared

Olympus Endoscopic System Lumbar Hernia Discectomy and Its Ancillary Equipment

K982133510(k) TraditionalCleared Oct 22, 1998127-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

The Olympus Optical Co. · HRX Arthroscope

Cleared on Oct 22, 1998 as substantially equivalent to K955471 (Sofamor Danek USA,Inc., 1995) and 3 other predicates after a 127-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided: Oct 22, 1998
Review: 127 days
Class: Class II
Product code: HRX
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K950130 (1995). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK950130 Micro-Endo (TM) InstrumentsSofamor Danek USA,Inc. · 1995
This deviceK982133 Olympus Endoscopic System Lumbar Hernia Discectomy and Its Ancillary…The Olympus Optical Co. · 1998
Descendant · cites it directly · 0 of its ownK043128 Olympus EndoarmOlympus Corporation · 2004

Most influential descendants

Showing 1 of 1 · See all

K043128Olympus EndoarmOlympus Corporation · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K950130	Micro-Endo (TM) Instruments	Sofamor Danek USA,Inc.	1995	—
0 (this device)	K982133	Olympus Endoscopic System Lumbar Hernia Discectomy and Its Ancillary Equipment	The Olympus Optical Co.	1998	—
+1	K043128	Olympus Endoarm	Olympus Corporation	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K982133, 1995–2004Source: 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.

Top candidate predicates for a new HRX device

#1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (5)

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
*	K955471	Incl Endoscope Summary page 4 …EDICATE OR LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS BEING CLAIMED: Sofamor Danek’s MED MicroEndoscopic Discectomy System, Sofamor Danek’s INCL Endoscopic System (K955471), Rigid Arthroscope (K950501), and MICRO- ENDO Instruments (K950130). 4. DEVICE DESCRIPTION The Olympus Endoscopic System for L…	Sofamor Danek USA,Inc.	1995	—
*	K950501	Danek Rigid Arthroscope Summary page 4 …EVICE TO WHICH EQUIVALENCE IS BEING CLAIMED: Sofamor Danek’s MED MicroEndoscopic Discectomy System, Sofamor Danek’s INCL Endoscopic System (K955471), Rigid Arthroscope (K950501), and MICRO- ENDO Instruments (K950130). 4. DEVICE DESCRIPTION The Olympus Endoscopic System for Lumbar Hernia Discectomy and A…	Sofamor Danek USA,Inc.	1995	—
*	K950130	Micro-Endo (TM) Instruments Summary page 4 …IMED: Sofamor Danek’s MED MicroEndoscopic Discectomy System, Sofamor Danek’s INCL Endoscopic System (K955471), Rigid Arthroscope (K950501), and MICRO- ENDO Instruments (K950130). 4. DEVICE DESCRIPTION The Olympus Endoscopic System for Lumbar Hernia Discectomy and Accessories consist of the following com…	Sofamor Danek USA,Inc.	1995	—
*	K951354	Olympus Arthroscopy System Summary page 5 …ar herniated disc material, and lumbar paravertebral tissue. The proposed Olympus Endoscope is also substantially equivalent to the Olympus Endoscope described in 510(k) K951354, in optical characteristics and Olympus Optical Co. Ltd. 510(k) 6/16/98 Endoscopic System for Lumbar Hernia Discectomy Page D-2…	Olympus America, Inc.	1995	—
*	—	Sofamor Danek’s MED MicroEndoscopic Discectomy System Named without a submission number			—
†	K960068	SH-1 Surgical Holder for Telescope	Olympus America, Inc.	1997	—

Also cleared against K955471: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K043128	Olympus Endoarm	Olympus Corporation	2004	0

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 4 ancestors has a recall.
Of its descendants, K043128 (Olympus Corporation, 2004) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K955471.

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?

Olympus Endoscopic System for Lumbar Hernia Discectomy and its ancillary equipment are intended for visualizing lumbar disc, lumbar herniated disc material and lumbar paravertebral tissue, and aiding in search and removal of vertebral bone and nucleus material.

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/K982133 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982133: Olympus Endoscopic System Lumbar Hernia Discectomy and Its Ancillary Equipment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982133

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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