Disposable Hand Switching Pencil, Rocker Switch, One Piece and One Piece Holster Models SB 313 RS, SB 313 RSH
FDA 510(k) K982742 · New Deantronics Taiwan , Ltd.
510(k) numberK982742
Submission
- Device name
- Disposable Hand Switching Pencil, Rocker Switch, One Piece and One Piece Holster Models SB 313 RS, SB 313 RSH
- Applicant
- New Deantronics Taiwan , Ltd.
Boulder, CO, US - Received
- August 6, 1998
- Decision date
- September 14, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K251492 | Irrigation Tubing Bipolar Cord SetGEI · Traditional | 06/29/2026SE |
| K251899 | E BlatorGEI · Traditional | 10/01/2025SE |
| K202962 | Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button…GEI · Traditional | 11/20/2020SE |
| K201221 | Electrosurgical GeneratorGEI · Traditional | 09/28/2020SE |
| K200455 | Trigger Switch and CordGEI · Traditional | 03/31/2020SE |
| K193004 | Monopolar CordGEI · Traditional | 12/19/2019SE |
| K191064 | Argon HandsetGEI · Traditional | 06/12/2019SE |
| K183126 | Electrosurgical accessoryGEI · Traditional | 05/08/2019SE |
| K183594 | Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic…GEI · Traditional | 02/19/2019SE |
| K180908 | Irrigation Tubing Bipolar Cord SetGEI · Traditional | 05/18/2018SE |
Questions and answers
When was Disposable Hand Switching Pencil, Rocker Switch, One Piece and One Piece Holster Models SB 313 RS, SB 313 RSH cleared by the FDA?
Disposable Hand Switching Pencil, Rocker Switch, One Piece and One Piece Holster Models SB 313 RS, SB 313 RSH (K982742) received a 510(k) decision of Substantially Equivalent on September 14, 1998, 39 days after the submission was received.
What is the product code of K982742?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.