Switchblade
FDA 510(k) K030890 · Snowden Pencer, Inc.
510(k) numberK030890
Submission
- Device name
- Switchblade
- Applicant
- Snowden Pencer, Inc.
Tucker, GA, US - Received
- March 21, 2003
- Decision date
- April 4, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
|---|---|---|
| K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…FBM · Traditional | 03/12/1996SE |
| K930666 | Reusable Laparoscopic Instruments W/ ElectrocauteryGEI · Traditional | 05/19/1994SE |
| K930667 | Reusable Laparoscopic InstrumentsGCJ · Traditional | 05/16/1994SE |
| K924148 | Diamond-Sharp(R) TrocarsHFI · Traditional | 02/28/1994SE |
| K924149 | Endo I/A ProbeGCJ · Traditional | 01/26/1993SE |
| K920985 | Snowden-Pencer Irrigation PumpHEI · Traditional | 06/09/1992SE |
| K920986 | Snowden-Pencer High Flow Insufflator, SP/88-9700HIF · Traditional | 06/04/1992SE |
| K913979 | Endo I/A Y SetHIF · Traditional | 11/27/1991SE |
| K913835 | Snowden-Pencer Insufflator Tubing SetHIF · Traditional | 11/07/1991SE |
| K861372 | Electrosurgical Cutting and Coagulation AccessoryGEI · Traditional | 06/19/1986SE |
Questions and answers
When was Switchblade cleared by the FDA?
Switchblade (K030890) received a 510(k) decision of Substantially Equivalent on April 4, 2003, 14 days after the submission was received.
What is the product code of K030890?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.