510(k) · Cleared
ClearedBlack and Black Electrosurgical Cutting and Coagulation Forceps and Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Black & Black Surgical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 18, 2008 as substantially equivalent to K033232 (Stryker Corp., 2004) after a 169-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Jan 18, 2008
- Review
- 169 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000348 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK000348 Colorado Microdissection NeedleStryker Leibinger · 2000
- 1 generation backK033232 Colorado Microdissection NeedleStryker Corp. · 2004
- This deviceK072124 Black and Black Electrosurgical Cutting and Coagulation Forceps and…Black & Black Surgical, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK143662 Bissinger Monopolar Forceps and CablesMedagent, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K143662Bissinger Monopolar Forceps and CablesMedagent, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000348 | Colorado Microdissection Needle | Stryker Leibinger | 2000 | — |
| −1 | K033232 | Colorado Microdissection Needle | Stryker Corp. | 2004 | — |
| 0 (this device) | K072124 | Black and Black Electrosurgical Cutting and Coagulation Forceps and Electrodes | Black & Black Surgical, Inc. | 2008 | — |
| +1 | K143662 | Bissinger Monopolar Forceps and Cables | Medagent, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K033232 | Colorado Microdissection NeedleSummary page 1…The Black and Black Surgical monopolar forceps and electrodes are substantially in function and intended use to the Colorado MicroDissection Needle (K033232), Valleylab Bayonet Forceps, Conmed Bayonet Straight Tip with Cable, Snowden-Pencer Endo-Plastic Electrosurgical Dissecto… | 2004 |
| * | — | Valleylab Bayonet Forceps Named without a submission number | |
| * | — | Conmed Bayonet Straight Tip with Cable Named without a submission number | |
| * | — | Snowden-Pencer Endo-Plastic Electrosurgical Dissector Named without a submission number | |
| * | — | Snowden-Pencer Monopolar Insulated Forceps Named without a submission number | |
| * | — | Olsen Hand Activated Monopolar Forceps Named without a submission number |
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 |
|---|---|---|---|
| K143662 | Bissinger Monopolar Forceps and Cables | 2015 | 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 8 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K143662 (Medagent, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K033232.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The Black and Black Surgical monopolar electrodes and forceps are reusable devices intended for use in surgical procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic, arthroscopic) where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072124: Black and Black Electrosurgical Cutting and Coagulation Forceps and Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072124
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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