Stryker Stiletto Electrosurgical Probe
FDA 510(k) K052141 · Stryker Endoscopy
510(k) numberK052141
Submission
- Device name
- Stryker Stiletto Electrosurgical Probe
- Applicant
- Stryker Endoscopy
San Jose, CA, US - Received
- August 8, 2005
- Decision date
- October 6, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code GEI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254185 | Potenza PrimeGEI · Traditional | Jeisys Medical Incorporated | 09/11/2026SE |
| K262364 | Ellian Enigma RF DeviceGEI · Traditional | Ellian Corp | 09/02/2026SE |
| K253859 | Scarlet Pro (Scarlet Pro)GEI · Traditional | VIOL Co., Ltd. | 08/27/2026SE |
| K252535 | Inno-Switch Laparoscopic InstrumentsGEI · Traditional | Taiwan Surgical Corporation | 08/25/2026SE |
| K261179 | AlphaTriPart - Monopolar MIC InstrumentsGEI · Traditional | Gimmi GmbH | 07/22/2026SE |
| K253504 | VolnewmerGEI · Traditional | Classys, Inc. | 07/13/2026SE |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional | Olympus Medical Systems Corp. | 07/01/2026SE |
| K253484 | Lutronic GeniusGEI · Traditional | Cynosure Lutronic Technology Corporation | 06/29/2026SE |
| K251492 | Irrigation Tubing Bipolar Cord SetGEI · Traditional | New Deantronics Taiwan , Ltd. | 06/29/2026SE |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingGEI · Traditional | Stryker Sustainability Solutions | 06/18/2026SE |
More from Stryker Sustainability Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K262369 | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair…MBI · Special | 07/30/2026SE |
| K253602 | Precision S 4K SinuscopeGWG · Traditional | 06/04/2026SE |
| K261037 | 780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemIZI · Traditional | 05/28/2026SE |
| K260185 | 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…GCJ · Special | 02/18/2026SE |
| K260108 | L12 LED Light Source with AIMOWN · Special | 02/12/2026SE |
| K254014 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with…GCJ · Special | 01/13/2026SE |
| K253888 | MOLLI 2 SystemNEU · Special | 12/31/2025SE |
| K252010 | SPY LaparoscopeGCJ · Special | 07/24/2025SE |
| K252012 | SPY Cystoscope/HysteroscopeHIH · Special | 07/18/2025SE |
| K250544 | Knotilus+ Biocomposite Knotless AnchorMAI · Traditional | 05/23/2025SE |
Questions and answers
When was Stryker Stiletto Electrosurgical Probe cleared by the FDA?
Stryker Stiletto Electrosurgical Probe (K052141) received a 510(k) decision of Substantially Equivalent on October 6, 2005, 59 days after the submission was received.
What is the product code of K052141?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.