SLT Bipolar Sheath
FDA 510(k) K981041 · Surgical Laser Technologies, Inc.
510(k) numberK981041
Submission
- Device name
- SLT Bipolar Sheath
- Applicant
- Surgical Laser Technologies, Inc.
Montgomeryville, PA, US - Received
- March 20, 1998
- Decision date
- August 27, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ERL – Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4250
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code ERL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243280 | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro…ERL · Traditional | W&H Dentalwerk Buermoos GmbH | 07/03/2025SE |
| K233958 | hekaDrillERL · Traditional | Zethon, Ltd. | 03/14/2024SE |
| K221184 | ORiGO SystemERL · Traditional | Bien-Air Surgery SA | 11/02/2022SE |
| K213221 | AMADEO, M-UK1015 (incl. attachments and accessories)ERL · Traditional | W&H Dentalwerk Buermoss GmbH | 05/26/2022SE |
| K212650 | Celeris, Disposable Sinus DebriderERL · Traditional | Gyrus Acmi, Inc. | 01/19/2022SE |
| K211490 | Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number…ERL · Special | Stryker Corporation | 06/09/2021SE |
| K200318 | UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver HandpieceERL · Traditional | KARL STORZ Endoscopy-America, Inc. | 10/22/2020SE |
| K190715 | EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set…ERL · Traditional | Interscope, Inc. | 12/13/2019SE |
| K180063 | OCM-G1 AttachmentERL · Special | The Anspach Effort, Inc. | 03/27/2018SE |
| K171840 | Stryker Consolidated Operating Room Equipment (CORE) 2 ConsoleERL · Traditional | Stryker Corporation | 09/15/2017SE |
More from Stryker Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K042211 | Modification to: Laserpro 810, 940, and 980 Diode Diode Laser SystemsGEX · Traditional | 11/08/2004SE |
| K023624 | SLT Venous Fiber Delivery Systems, Model: 0041-6772/0041-6781/0041-6752/0041-6761/0041-69…GEX · Traditional | 01/27/2003SE |
| K011409 | SLT Laserpro CTH Holmium Laser SystemGEX · Traditional | 06/14/2001SE |
| K010041 | SLT Diffuser FiberGEX · Traditional | 03/07/2001SE |
| K984018 | Hemosleeve, Model 4.0MM, 5.5MMGEI · Traditional | 03/15/1999SE |
| K983050 | Pneumatic Cutter SystemERL · Traditional | 11/25/1998SE |
| K972548 | SLT CL MD Contact Laser SystemGEX · Traditional | 04/21/1998SE |
| K980156 | SLT Select Fiber Delivery System and Contact TipsGEX · Traditional | 02/27/1998SE |
| K960821 | SLT Fumich Probe GuideGEX · Traditional | 05/16/1996SE |
| K954727 | SLT Multidimensional Contact Laser System (Modification)GEX · Traditional | 02/05/1996SE |
Questions and answers
When was SLT Bipolar Sheath cleared by the FDA?
SLT Bipolar Sheath (K981041) received a 510(k) decision of Substantially Equivalent on August 27, 1998, 160 days after the submission was received.
What is the product code of K981041?
The FDA product code is ERL – Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, a Class II (moderate risk) device regulated under 21 CFR 874.4250.