510(k) · Cleared
ClearedBicoag Coagulating Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Everest Medical Corp. · HIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
Cleared on Mar 12, 1998 as substantially equivalent to K945975 (Everest Medical Corp., 1994) after a 317-day review. Its family tree reaches back 1 generation to 1994. 7 later devices descend from it.
- Decided
- Mar 12, 1998
- Review
- 317 days
- Class
- Class II
- Product code
- HIN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945975 (1994). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK945975 Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp. · 1994
- This deviceK971565 Bicoag Coagulating ForcepsEverest Medical Corp. · 1998
- Descendant · cites it directly · 4 of its ownK012279 Patton TripolPatton Medical Corp. · 2002
- Descendant · 2 generations on · 3 of its ownK023813 Bipolar ForcepsRichard Wolf Medical Instruments Corp. · 2003
- Descendant · 3 generations on · 1 of its ownK113597 Mini-Lap Bipolar Electrocautery DevicesMinilap Technologies · 2012
- Descendant · cites it directly · 1 of its ownK984417 Bipolar Grasping Forceps Biq+Olympus America, Inc. · 1999
- Descendant · 4 generations on · 0 of its ownK172775 MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip…Teleflexmedical, Inc. · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K012279Patton TripolPatton Medical Corp. · 2002 · cites it directly4descendants
- K023813Bipolar ForcepsRichard Wolf Medical Instruments Corp. · 2003 · 2 generations on3descendants
- K113597Mini-Lap Bipolar Electrocautery DevicesMinilap Technologies · 2012 · 3 generations on1descendant
- K984417Bipolar Grasping Forceps Biq+Olympus America, Inc. · 1999 · cites it directly1descendant
- K172775MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip HandleTeleflexmedical, Inc. · 2018 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945975 | Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps | Everest Medical Corp. | 1994 | — |
| 0 (this device) | K971565 | Bicoag Coagulating Forceps | Everest Medical Corp. | 1998 | — |
| +1 | K012279 | Patton Tripol | Patton Medical Corp. | 2002 | — |
| +2 | K023813 | Bipolar Forceps | Richard Wolf Medical Instruments Corp. | 2003 | — |
| +3 | K113597 | Mini-Lap Bipolar Electrocautery Devices | Minilap Technologies | 2012 | — |
| +1 | K984417 | Bipolar Grasping Forceps Biq+ | Olympus America, Inc. | 1999 | — |
| +4 | K172775 | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle | Teleflexmedical, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 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 HIN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K945975 | Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsSummary page 1….92. The device is a Class Il medical device. The Tubal Sterilization device is similar to Everest Medical’s current laparoscopic BICOAG® forceps submitted on 510(k) no. K945975 and the pre-ennactment Tubal sterilization Wolf Kleppinger Forceps. Performance testing has been submitted to support the safety… | 1994 |
| * | — | pre-enactment Tubal sterilization Wolf Kleppinger Forceps Named without a submission number |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All HIN devicesHIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HIN
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · HIN
Too few HIN 510(k)s in any year since 2007 to give a median.
Recalls per year · HIN
No recall names HIN since 2007.
Adverse event reports per year · HIN
43in 2025
MAUDE reports naming product code HIN, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 2 | — | 0 | 6 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 14 |
| 2014 | 1 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 29 |
| 2025 | 0 | — | 0 | 43 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Laparoscopic grasping of tissue.
Laparoscopic bipolar coagulation.
Laparoscopic contraceptive coagulation of the Fallopian tissue and may be used to achieve hemostasis following transection of the Fallopian tube.
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/K971565 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971565: Bicoag Coagulating Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971565
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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