510(k) Report

510(k) · Cleared

Cleared

Stingray Ultralite Disposable Irrigating Bipolar Forceps

K102752510(k) TraditionalCleared Nov 9, 2011412-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

Stingray Surgical Products, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Nov 9, 2011 as substantially equivalent to K080187 (Olsen Medical, 2008) and 1 other predicate after a 412-day review. Its family tree reaches back 6 generations to 1992.

Decided
Nov 9, 2011
Review
412 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
2

Its longest line of descent runs back 6 generations to K923332 (1992). 11 ancestors in all, the oldest K884656 (1988). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 1 other ancestor2000: 1 other ancestor1988: 1 other ancestor1998: 1 other ancestor1997: 1 other ancestorK923332 · Electrosurgical Electrodes · Premier Dental Products Co. · 1992K970987 · Electrosurgical Electrode · Fusion Medical Technologies, Inc. · 1997K992931 · Non-Stick Bipolar Forceps · Silverglide Surgical Technologies · 1999K051429 · Claris Non-Stick Bipolar Forceps · Guenter Bissinger Medizintechnik GmbH · 2005K070997 · Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro Bipolar Reusable Cables, Model 5015-XX · Pro-Med Instruments GmbH · 2007K083162 · Stingray Electrosurgical Forceps · Stingray Surgical Products, Inc. · 2009 · recalled198519901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors4 generations back: 1 other ancestor5 generations back: 1 other ancestor K083162 · Stingray Electrosurgical Forceps · Stingray Surgical Products, Inc. · 2009 · recalledK070997 · Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro Bipolar Reusable Cables, Model 5015-XX · Pro-Med Instruments GmbH · 2007K051429 · Claris Non-Stick Bipolar Forceps · Guenter Bissinger Medizintechnik GmbH · 2005K992931 · Non-Stick Bipolar Forceps · Silverglide Surgical Technologies · 1999K970987 · Electrosurgical Electrode · Fusion Medical Technologies, Inc. · 1997K923332 · Electrosurgical Electrodes · Premier Dental Products Co. · 1992−50
  1. Root · 6 generations backK923332 Electrosurgical ElectrodesPremier Dental Products Co. · 1992
  2. 5 generations backK970987 Electrosurgical ElectrodeFusion Medical Technologies, Inc. · 1997
  3. 4 generations backK992931 Non-Stick Bipolar ForcepsSilverglide Surgical Technologies · 1999
  4. 3 generations backK051429 Claris Non-Stick Bipolar ForcepsGuenter Bissinger Medizintechnik GmbH · 2005
  5. 2 generations backK070997 Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro…Pro-Med Instruments GmbH · 2007
  6. 1 generation backK083162 Stingray Electrosurgical ForcepsStingray Surgical Products, Inc. · 2009 · Recalled
  7. This deviceK102752 Stingray Ultralite Disposable Irrigating Bipolar ForcepsStingray Surgical Products, Inc. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K923332Electrosurgical ElectrodesPremier Dental Products Co.1992—
−5K970987Electrosurgical ElectrodeFusion Medical Technologies, Inc.1997—
−4K992931Non-Stick Bipolar ForcepsSilverglide Surgical Technologies1999—
−3K051429Claris Non-Stick Bipolar ForcepsGuenter Bissinger Medizintechnik GmbH2005—
−2K070997Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro Bipolar…Pro-Med Instruments GmbH2007—
−1K083162Stingray Electrosurgical ForcepsStingray Surgical Products, Inc.20091
0 (this device)K102752Stingray Ultralite Disposable Irrigating Bipolar ForcepsStingray Surgical Products, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199710
199810
200010
200810
FIG. 1 — Lineage of K102752, 1992–2011Source: 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
*K080187Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps
Summary page 1
…ally marketed devices: Stingray Ultralite Disposable Irrigation Forceps are substantially equivalent to Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps K0801 87 and Stingray Elecirosurgical Forceps K083 162 based on the device similarity to predicated device. 3. Indications for Use (in…
Olsen Medical20081
*K083162Stingray Electrosurgical Forceps
Summary page 1
…osable Irrigation Forceps are substantially equivalent to Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps K0801 87 and Stingray Elecirosurgical Forceps K083 162 based on the device similarity to predicated device. 3. Indications for Use (intended use) Designed to grasp, manipulate and…
Stingray Surgical Products, Inc.20091

Also cleared against K080187: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 19 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
  • 4 of the 11 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K080187.

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. 2011, 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?

Designed to grasp, manipulate and coagulate selected tissue for single use in general surgical procedures. These forceps can be sold with or without irrigation and are provided sterile. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator and irrigation module. Stingray Ultralite Disposable Irrigation Forceps can be used with bipolar coagulation current. Coagulation is achieved using electrosurgical…

Read the full statement (107 words)

Designed to grasp, manipulate and coagulate selected tissue for single use in general surgical procedures. These forceps can be sold with or without irrigation and are provided sterile. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator and irrigation module. Stingray Ultralite Disposable Irrigation Forceps can be used with bipolar coagulation current. Coagulation is achieved using electrosurgical energy generated by the electro surgical generator unit and activated by a footswitch. The Stingray Ultralite Disposable Irrigation 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.

Indications for use as stated in the FDA summary.

Also cleared against K080187

2 other devices cite the same predicate.

  • K182773Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use…Faulhaber Pinzetten Ohg · 2019
  • K110924Disposable Spetzler-Malis Dual Irrigating Bipolar ForcepsSynergetics, Inc. · 20113 recalls

More from Stingray Surgical Products, Inc.

2 FDA decisions under this applicant name. See the company

  • K083162Stingray Electrosurgical ForcepsStingray Surgical Products, Inc. · 20091 recall

Recent decisions in GEI

The GEI category page

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  • K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch…Stryker Instruments · 2026
  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
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  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K102752 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102752: Stingray Ultralite Disposable Irrigating Bipolar Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102752

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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