510(k) · Cleared
ClearedErbe Biclamp Open and Laparoscopic Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erbe USA, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 14, 2004 as substantially equivalent to K981916 (Valleylab, Inc., 1998) after a 353-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- Oct 14, 2004
- Review
- 353 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932293 (1994). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 1 generation backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- This deviceK033421 Erbe Biclamp Open and Laparoscopic InstrumentsErbe USA, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK091259 Ethicon Endo-Surgery Flexible Bipolar Hemostasis ForcepsEthicon Endo-Surgery, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK060170 Erbe Biclamp Open and Laparoscopic InstrumentsErbe USA, Inc. · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −1 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| 0 (this device) | K033421 | Erbe Biclamp Open and Laparoscopic Instruments | Erbe USA, Inc. | 2004 | — |
| +1 | K091259 | Ethicon Endo-Surgery Flexible Bipolar Hemostasis Forceps | Ethicon Endo-Surgery, Inc. | 2010 | — |
| +1 | K060170 | Erbe Biclamp Open and Laparoscopic Instruments | Erbe USA, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K981916 | Ligasure Vessel Sealing SystemSummary page 1…ode: GEl and HGI Legally Marketed Valleylab Inc. LigaSure TM Open and Laparoscopic Predicate Device: Instruments, 510(k) Number: K981916 Device Description: The ERBE BiClamp TM Open and Laparoscopic Instruments are used with an ERBE VIO Electrosurgical Generator (ES… | 1998 |
What descends from it? (2)
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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K091259 (Ethicon Endo-Surgery, Inc., 2010) has gone furthest, with 0 descendants of its own.
- 15 other devices also cite its predicate K981916.
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?
The ERBE BiClamp TM Open and Laparoscopic Instruments are intended for use in general surgery, laparoscopic, gynecologic, urological, and thoracic procedures where fusion of vessels or tissues is desired. The devices can be used on vessels up to 7 mm and bundles as large as will fit in the jaws of the instrument. A vessel fusion is created by the application of bipolar electrosurgical RF energy (coagulation) to the vessels placed between the jaws of the…
Read the full statement (255 words)
The ERBE BiClamp TM Open and Laparoscopic Instruments are intended for use in general surgery, laparoscopic, gynecologic, urological, and thoracic procedures where fusion of vessels or tissues is desired. The devices can be used on vessels up to 7 mm and bundles as large as will fit in the jaws of the instrument. A vessel fusion is created by the application of bipolar electrosurgical RF energy (coagulation) to the vessels placed between the jaws of the instrument.
The ERBE BiClampTM Open and Laparoscopic Instruments are designed for use with an ERBE VIO Electrosurgical Generator (ESU) System having an Optional Bipolar Mode/ BiClamp TM upgrade and the multi-function receptacle. Not recommended for use with other manufacturer's generators.
The indications for use with Open Instruments include: general surgery, gynecologic, urological, and thoracic procedures where fusion of vessels and tissue bundles is performed including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), Nissen fundoplication, adhesiolysis (lysis of adhesions), oophorectomy, etc.
The indications for use with Laparoscopic Instruments include: all laparoscopic procedures (including gynecologic, general, urological, and thoracic surgery) where fusion of vessels or tissue bundles is performed including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholecystectomies (gall bladder procedures), Nissen fundoplication, adhesiolysis (lysis of adhesions), oophorectomy, etc.
CAUTION: Vessel fusion can be affected by patient factors such as age, elasticity of vessels, thickness of vessel walls, etc.; therefore, the physician should review each vessel fusion for seal integrity. This device is not effective for use in tubal sterilization/tubal coagulation for sterilization purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033421: Erbe Biclamp Open and Laparoscopic Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033421
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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