510(k) K201884
- Device
- ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm
- Applicant
- Microline Surgical, Inc.
- 510(k) number
- K201884
- Product code
- GEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-10-21
- Date received
- 2020-07-08
- Regulation
- 878.4400
- Classification name
- Electrosurgical, Cutting & Coagulation & Accessories
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Scott Marchand Davis
- Address
- 50 Dunham Rd., Suite 1500 Beverly MA US 01915 01915
FDA Registration Numbers#
- 2184009
- 1221934
- 3013176080
- 9680952
- 3003678543
- 3009380063
- 3009881188
- 2245590
- 2431166
- 3006849754
- 2029275
- 3004111573
- 2133786
- 3009882464
- 3013283620
- 3012447612
- 3007710878
- 2648623
- 3004122598
- 3015612252
- 3010280625
- 1929938
- 3012497308
- 3009762450
- 3010288205
- 3012322232
- 3018242561
- 1836161
- 2020394
- 1222993
- 3006891627
- 9610614
- 2955842
- 3011879048
- 3013466775
- 2032098
- 3004636440
- 3012790575
- 9614969
- 3007583504
- 3040335671
- 3009420598
- 3010164891
- 3017892510
- 3019569846
- 2434839
- 8030607
- 9611827
- 2248148
- 8043746
- 3018126215
- 3014479313
- 3022320321
- 3005467144
- 3013944123
- 3020623326
- 3027988352
- 3007748817
- 3004519921
- 2024024
- 3009736547
- 3016496662
- 3017450375
- 3030839824
- 3006696607
- 3006404071
- 3012818475
- 3015542154
- 2182291
- 3015779311
- 2124215
- 1526611
- 9614279
- 3007007790
- 3031571464
- 2183715
- 8030967
- 1000523114
- 3008915316
Source Documents#
Other 510(k) Records For Product Code GEI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254196 | HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) | Ethicon Endo-Surgery, LLC | 2026-09-17 |
| K261959 | Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102) | Stryker Instruments | 2026-09-17 |
| K261070 | LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated | Covidien, LLC | 2026-09-15 |
| K254185 | Potenza Prime | Jeisys Medical Incorporated | 2026-09-11 |
| K262364 | Ellian Enigma RF Device | Ellian Corp | 2026-09-02 |
| K253859 | Scarlet Pro (Scarlet Pro) | VIOL Co., Ltd. | 2026-08-27 |
| K252535 | Inno-Switch™ Laparoscopic Instruments | Taiwan Surgical Corporation | 2026-08-25 |
| K261179 | AlphaTriPart - Monopolar MIC Instruments | Gimmi GmbH | 2026-07-22 |
| K253504 | Volnewmer™ | Classys, Inc. | 2026-07-13 |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) | Olympus Medical Systems Corp. | 2026-07-01 |
| K251492 | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. | 2026-06-29 |
| K253484 | LUTRONIC GENIUS | Cynosure Lutronic Technology Corporation | 2026-06-29 |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | Stryker Sustainability Solutions | 2026-06-18 |
| K253634 | CoolSeal Generator® (CSL-200-90) | Hologic, Inc. | 2026-06-17 |
| K261833 | NEUROMARK System (NMK00301) | Neurent Medical , Ltd. | 2026-06-16 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases