510(k) Report

510(k) · Cleared

Cleared

Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps

K182773510(k) TraditionalCleared Oct 8, 2019372-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Faulhaber Pinzetten Ohg · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Oct 8, 2019 as substantially equivalent to K101080 (Egon Faulhaber Surgical Instruments Pinzetten, 2010) and 1 other predicate after a 372-day review. Its family tree reaches back 2 generations to 1988. 2 later devices descend from it.

Decided
Oct 8, 2019
Review
372 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K884656 (1988). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2000: 1 other ancestor2023: 1 descendant cleared2020: 1 descendant clearedK884656 · Disposable Bipolar Cord and Bipolar Forcep · Dermacare · 1988 · recalledK080187 · Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps · Olsen Medical · 2008 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor 1 generation forward: 2 descendants K080187 · Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps · Olsen Medical · 2008 · recalledK884656 · Disposable Bipolar Cord and Bipolar Forcep · Dermacare · 1988 · recalled0
  1. Root · 2 generations backK884656 Disposable Bipolar Cord and Bipolar ForcepDermacare · 1988 · Recalled
  2. 1 generation backK080187 Olsen Medical Single Use Bayonet Bipolar Irrigating ForcepsOlsen Medical · 2008 · Recalled
  3. This deviceK182773 Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick…Faulhaber Pinzetten Ohg · 2019
  4. Descendant · cites it directly · 1 of its ownK191847 Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt…Adeor Medical AG · 2020
  5. Descendant · cites it directly · 0 of its ownK233351 Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip…Hg Innovations, Ltd. · 2023

Most influential descendants

Showing 2 of 2 · See all
  • K191847Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick…Adeor Medical AG · 2020 · cites it directly1descendant
  • K233351Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable…Hg Innovations, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K884656Disposable Bipolar Cord and Bipolar ForcepDermacare19881
−1K080187Olsen Medical Single Use Bayonet Bipolar Irrigating ForcepsOlsen Medical20081
0 (this device)K182773Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar…Faulhaber Pinzetten Ohg2019—
+1K191847Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use…Adeor Medical AG2020—
+1K233351Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable…Hg Innovations, Ltd.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202310
FIG. 1 — Lineage of K182773, 1988–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K101080Non Stick Bipolar Forceps Model 07/XXX, Bipolar Forceps Model 08/XXX, Monopolar Forceps…
Summary page 4
…cation name: Electrosurgical, Cutting & Coagulation & Accessories Product code: GEI Regulation number: 878.4400 Classification: Class II Predicate Device: K101080 Egon Faulhaber Pinzetten Reference Devices: K080187 Olsen Medical 3. Predicate devices 3.1 Primary predicate device…
Egon Faulhaber Surgical Instruments Pinzetten2010—
*K080187Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps
Summary page 4
…& Accessories Product code: GEI Regulation number: 878.4400 Classification: Class II Predicate Device: K101080 Egon Faulhaber Pinzetten Reference Devices: K080187 Olsen Medical 3. Predicate devices 3.1 Primary predicate device Device Owner/ 510(k) # P…
Olsen Medical20081

Also cleared against K101080: 2 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K191847Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick…Adeor Medical AG20201
K233351Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable…Hg Innovations, Ltd.20230

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 31 years and passes through 3 companies; a new generation was cleared every 19.5 years on median.
  • 2 of the 4 ancestors have a recall of any class.
  • Of its descendants, K191847 (Adeor Medical AG, 2020) has gone furthest, with 1 descendant of its own.
  • 2 other devices also cite its predicate K101080.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

Faulhaber Single Use Non-Stick Bipolar Forceps sterile/ non-sterile and Single Use Non-Stick Bipolar Irrigating Forceps sterile/ non-sterile are intended for use by a physician familar with electrosurgery for bipolar coagulation and irrigation of tissue for general surgery. The bipolar forceps are used with the bipolar output for standard electrosurgical generators. The products are intended for single use and are provided sterile as well as non-sterile.…

Read the full statement (151 words)

Faulhaber Single Use Non-Stick Bipolar Forceps sterile/ non-sterile and Single Use Non-Stick Bipolar Irrigating Forceps sterile/ non-sterile are intended for use by a physician familar with electrosurgery for bipolar coagulation and irrigation of tissue for general surgery. The bipolar forceps are used with the bipolar output for standard electrosurgical generators. The products are intended for single use and are provided sterile as well as non-sterile.

Products supplied non-sterile must be cleaned, disinfected and sterilized prior to their use by the validated cleaning, disinfection and sterilization process.

The bipolar forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

The types of surgery intended are

- General surgery

- Laryngeal coagulation

- Orthopedic coagulation

- Thoracic coagulation

- Neurosurgical coagulation

- Gynecological coagulation (except for use in female sterilization)

- Urological coagulation

- Ear-, Nose-, Throat coagulation

Indications for use as stated in the FDA summary.

Also cleared against K101080

2 other devices cite the same predicate.

  • K143662Bissinger Monopolar Forceps and CablesMedagent, Inc. · 2015
  • K131012Sutter Bipolar Forceps - SuperglissSutter Medizintechnik GmbH · 2013

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The GEI category page

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https://510kreport.com/device/K182773 · printed Nov 6, 2026

Cite this page

510(k) Report. “K182773: Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182773

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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