Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))
FDA 510(k) K242370 · Medline Industries, LP
510(k) numberK242370
Submission
- Device name
- Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))
- Applicant
- Medline Industries, LP
Northfiled, IL, US - Received
- August 9, 2024
- Decision date
- December 19, 2024
- 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 |
|---|---|---|
| K253526 | NAMIC Dilator and SheathDYB · Traditional | 07/29/2026SE |
| K254287 | Medline Reusable Blood Pressure CuffDXQ · Traditional | 06/22/2026SE |
| K253322 | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant…BZE · Traditional | 03/25/2026SE |
| K251687 | Konig Bell Circumcision ClampHFX · Traditional | 02/25/2026SE |
| K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)DXC · Traditional | 11/20/2025SE |
| K250345 | Medline Bag DecanterLHI · Traditional | 10/24/2025SE |
| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…BTT · Traditional | 07/02/2025SE |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemJDR · Traditional | 04/11/2025SE |
| K242844 | Medline Level 4 Surgical Gown with Breathable SleevesFYA · Traditional | 02/26/2025SE |
| K241778 | Hudson RCI Comfort Flo® CubCannulaBTT · Traditional | 12/19/2024SE |
Questions and answers
When was Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A)) cleared by the FDA?
Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A)) (K242370) received a 510(k) decision of Substantially Equivalent on December 19, 2024, 132 days after the submission was received.
What is the product code of K242370?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.