510(k) · Cleared
ClearedBipolar Forceps Set (Modular)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 7, 1998 after an 88-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jul 7, 1998
- Review
- 88 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK981321 Bipolar Forceps Set (Modular)Richard Wolf Medical Instruments Corp. · 1998
- Descendant · cites it directly · 0 of its ownK990147 Bipolar Forceps, Kleppinger Insert, Model #'S…Richard Wolf Medical Instruments Corp. · 1999
Most influential descendants
Showing 1 of 1 · See all- K990147Bipolar Forceps, Kleppinger Insert, Model #'S 8393.741,8393.771,8394.741,8394.771Richard Wolf Medical Instruments Corp. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981321 | Bipolar Forceps Set (Modular) | Richard Wolf Medical Instruments Corp. | 1998 | — |
| +1 | K990147 | Bipolar Forceps, Kleppinger Insert, Model #'S… | Richard Wolf Medical Instruments Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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? (1)
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 |
|---|---|---|---|
| * | — | Kleppinger bipolar forceps 8383.21, 8384.21 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 |
|---|---|---|---|
| K990147 | Bipolar Forceps, Kleppinger Insert, Model #'S 8393.741,8393.771,8394.741,8394.771 | 1999 | 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?
- Of its descendants, K990147 (Richard Wolf Medical Instruments Corp., 1999) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
For the coagulation of tubes, tissue coagulation and vascular coagulation to stop bleedings under endoscopic vision.
For therapy in connection with endoscopic accessories used in medical specialties such as urology, gynecology. surgery.
Not 10 be used for female sterilization (coagulation of fallopian tbes).
Contraindications are inflammations or bacterial contamination of wounds in the operation site. Contraindications directly related to the product are currently unknown. The attending physician must determine if the intended use is appropriate based on the general condition of the patient. For further instructions, refer to the latest medical literature.
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/K981321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981321: Bipolar Forceps Set (Modular).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981321
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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