510(k) · Cleared
ClearedCoopersurgical Laparoscopic Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CooperSurgical, Inc. · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Apr 10, 2003 as substantially equivalent to K932832 (Marlo Surgical Technology, 1994) and 1 other predicate after a 357-day review. Its family tree reaches back 1 generation to 1994. 11 later devices descend from it.
- Decided
- Apr 10, 2003
- Review
- 357 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K932832 (1994). 2 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK932832 Primus Insulated ForcepsMarlo Surgical Technology · 1994
- This deviceK021237 Coopersurgical Laparoscopic InstrumentsCooperSurgical, Inc. · 2003
- Descendant · cites it directly · 10 of its ownK043013 Miltex Laparoscopic InstrumentsMiltex, Inc. · 2005
- Descendant · 2 generations on · 8 of its ownK052759 Dan Monopolar Lap AccessoriesDannoritzer Medizintechnik GmbH & Co. KG · 2006 · Recalled
- Descendant · 3 generations on · 7 of its ownK081503 Aed Monopolar Lap AccessoriesNational Advanced Endoscopy Devices, Inc. · 2008
- Descendant · 4 generations on · 6 of its ownK103508 Unmiax Laparoscopic InstrumentUnimax Medical Systems, Inc. · 2011
- Descendant · 5 generations on · 1 of its ownK142208 Monopolar Laparascopic AccessoriesUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2015
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K043013Miltex Laparoscopic InstrumentsMiltex, Inc. · 2005 · cites it directly10descendants
- K052759Dan Monopolar Lap AccessoriesDannoritzer Medizintechnik GmbH & Co. KG · 2006 · 2 generations on8descendants
- K081503Aed Monopolar Lap AccessoriesNational Advanced Endoscopy Devices, Inc. · 2008 · 3 generations on7descendants
- K103508Unmiax Laparoscopic InstrumentUnimax Medical Systems, Inc. · 2011 · 4 generations on6descendants
- K142208Monopolar Laparascopic AccessoriesUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2015 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932832 | Primus Insulated Forceps | Marlo Surgical Technology | 1994 | — |
| 0 (this device) | K021237 | Coopersurgical Laparoscopic Instruments | CooperSurgical, Inc. | 2003 | — |
| +1 | K043013 | Miltex Laparoscopic Instruments | Miltex, Inc. | 2005 | — |
| +2 | K052759 | Dan Monopolar Lap Accessories | Dannoritzer Medizintechnik GmbH & Co. KG | 2006 | 1 |
| +3 | K081503 | Aed Monopolar Lap Accessories | National Advanced Endoscopy Devices, Inc. | 2008 | — |
| +4 | K103508 | Unmiax Laparoscopic Instrument | Unimax Medical Systems, Inc. | 2011 | — |
| +5 | K142208 | Monopolar Laparascopic Accessories | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 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 HET? 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 HET device
- #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 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 |
|---|---|---|---|
| * | K932832 | Primus Insulated ForcepsSummary page 1…issector, Electrosurgical instruments, Endoscopic Instruments. Predicate Device [21 CFR 807.92(a)(3)] 0 Primus Insulated Forceps - Marlow Surgical Technology - K932832 Family of Primus Forceps; Graspers and Dissectors - Marlow Surgical Technology - K944563 The subject devices hav… | 1994 |
| * | K944563 | Family of Primus Forceps: Graspers/Dissectors/Suturers/Needle DriversSummary page 1…0 Primus Insulated Forceps - Marlow Surgical Technology - K932832 Family of Primus Forceps; Graspers and Dissectors - Marlow Surgical Technology - K944563 The subject devices have the same indications for use as the predicates, have stainless steel jaws, are both sold non-ste… | 1994 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043013 | Miltex Laparoscopic Instruments | 2005 | 10 |
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.
- Of its descendants, K043013 (Miltex, Inc., 2005) has gone furthest, with 10 descendants of its own.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HET
269in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HET
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HET
4,513in 2025
MAUDE reports naming product code HET, 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 | 0 | — | 0 | 181 |
| 2008 | 3 | 176 | 4 | 359 |
| 2009 | 1 | — | 1 | 403 |
| 2010 | 1 | — | 0 | 214 |
| 2011 | 2 | — | 0 | 417 |
| 2012 | 2 | — | 0 | 1,118 |
| 2013 | 2 | — | 0 | 1,035 |
| 2014 | 0 | — | 0 | 175 |
| 2015 | 2 | — | 1 | 124 |
| 2016 | 0 | — | 0 | 205 |
| 2017 | 2 | — | 0 | 89 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 2 | — | 0 | 44 |
| 2020 | 2 | — | 0 | 49 |
| 2021 | 4 | 269 | 0 | 132 |
| 2022 | 1 | — | 1 | 216 |
| 2023 | 0 | — | 4 | 824 |
| 2024 | 0 | — | 0 | 3,496 |
| 2025 | 2 | — | 0 | 4,513 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The devices are designed to manipulate tissue, organs, or bowel during laparoscopic surgery. The secondary function is to provide monopolar electrocautery capability to dissect and coagulate tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021237 · printed Nov 3, 2026
Cite this page
510(k) Report. “K021237: Coopersurgical Laparoscopic Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K021237
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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