510(k) · Cleared
ClearedMedamicus Epidural Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medamicus, Inc. · GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Cleared on Mar 1, 2000 as substantially equivalent to K990705 (Medamicus, Inc., 1999) and 1 other predicate after an 89-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Mar 1, 2000
- Review
- 89 days
- Class
- Class II
- Product code
- GZB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K932323 (1993). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 1 generation backK990705 Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific…Medamicus, Inc. · 1999 · Recalled
- This deviceK994097 Medamicus Epidural IntroducerMedamicus, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK013120 Percutaneous Introducer Set, Model 042294 and Kit Model 3550-18Medamicus, Inc. · 2002
Most influential descendants
Showing 1 of 1 · See all- K013120Percutaneous Introducer Set, Model 042294 and Kit Model 3550-18Medamicus, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932323 | Percutaneous Introducer | Medamicus, Inc. | 1993 | — |
| −1 | K990705 | Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator… | Medamicus, Inc. | 1999 | 1 |
| 0 (this device) | K994097 | Medamicus Epidural Introducer | Medamicus, Inc. | 2000 | — |
| +1 | K013120 | Percutaneous Introducer Set, Model 042294 and Kit Model 3550-18 | Medamicus, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
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 GZB? 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 GZB device
- #1 K221376 Nalu Neurostimulation Systemscore 8.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K990705 | Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator SetSummary page 1…Contact Dennis S. Madison Vice President, Quality Assurance/Regulatory Affairs 612-559-2613, Fax: 612-559-7548 Predicate Devices Coaxial Dilator from MedAmicus, Inc. (K990705) Introde INT-8 from ANS (Neuromed), Inc. (K930242) - Device Description Information Intended Use The MedAmicus Epidural Introd… | 1999 |
| * | K930242 | Introde Int-8Summary page 1…y Assurance/Regulatory Affairs 612-559-2613, Fax: 612-559-7548 Predicate Devices Coaxial Dilator from MedAmicus, Inc. (K990705) Introde INT-8 from ANS (Neuromed), Inc. (K930242) - Device Description Information Intended Use The MedAmicus Epidural Introducer is intended to be used in the same manner as… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013120 | Percutaneous Introducer Set, Model 042294 and Kit Model 3550-18 | 2002 | 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?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 5.6 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K013120 (Medamicus, Inc., 2002) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K990705.
How does its category compare?
All GZB devicesGZB Stimulator, Spinal-Cord, Implanted (Pain Relief): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GZB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GZB
149in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZB
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZB
313in 2025
MAUDE reports naming product code GZB, 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 | 2 | — | 0 | 201 |
| 2008 | 1 | — | 1 | 68 |
| 2009 | 3 | 62 | 0 | 59 |
| 2010 | 1 | — | 1 | 157 |
| 2011 | 4 | 67 | 0 | 471 |
| 2012 | 2 | — | 0 | 1,090 |
| 2013 | 2 | — | 0 | 4,428 |
| 2014 | 2 | — | 0 | 10,849 |
| 2015 | 2 | — | 0 | 7,507 |
| 2016 | 2 | — | 0 | 4,556 |
| 2017 | 2 | — | 0 | 5,511 |
| 2018 | 1 | — | 0 | 5,244 |
| 2019 | 4 | 149 | 0 | 643 |
| 2020 | 2 | — | 0 | 466 |
| 2021 | 1 | — | 0 | 332 |
| 2022 | 1 | — | 0 | 209 |
| 2023 | 0 | — | 0 | 236 |
| 2024 | 1 | — | 0 | 318 |
| 2025 | 0 | — | 0 | 313 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
For percutaneous introduction, manipulation, and removal of epidural stimulation leads.
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/K994097 · printed Nov 5, 2026
Cite this page
510(k) Report. “K994097: Medamicus Epidural Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K994097
Report an extraction error
Are you the manufacturer?
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