510(k) K161086
- Device
- Reprocessed Harmonic Shears With Adaptive Tissue Technology (36 Cm), Reprocessed Harmonic Shears With Adaptive Tissue Technology (23cm)
- Applicant
- Sterilmed, Inc.
- 510(k) number
- K161086
- Product code
- NUJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-09-20
- Date received
- 2016-04-18
- Regulation
- 878.4400
- Classification name
- Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
- 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
- Patricia Kaufman
- Address
- 5010 Cheshire Pkwy. Suite 2 Plymouth MN US 55446 55446
FDA Registration Numbers#
- 1018470
- 3005575604
- 3017210488
- 3021477808
- 3030733800
- 2320762
- 3009350690
- 1056128
- 1055236
- 3030153385
- 3011024991
- 3014023545
- 3015453963
- 3017196117
- 2030624
- 2032112
- 3005467144
- 2011171
- 3032391
- 3020163307
- 1054241
- 3015988948
- 1061124
- 1526711
- 1650907
Source Documents#
Other 510(k) Records For Product Code NUJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232511 | Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) | Surgical Instrument Service and Savings, Inc. | 2024-04-29 |
| K230251 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) | Stryker Sustainability Solutions | 2023-03-28 |
| K220411 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) | Stryker Sustainability Solutions | 2022-05-13 |
| K211203 | Green OR Reprocessed Aquamantys Bipolar Sealer | Green Or, LLC | 2022-04-07 |
| K191073 | Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter | Vein 360, LLC | 2019-10-22 |
| K182588 | Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2018-10-31 |
| K180499 | Reprocessed LigaSure Maryland Jaw Sealer/Divider | Stryker Sustainability Solutions | 2018-04-23 |
| K180451 | Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider | Stryker Sustainability Solutions | 2018-04-20 |
| K173214 | NES Reprocessed RF Stylet (RFS) | Northeast Scientific, Inc. (Nes) | 2018-03-27 |
| K173740 | Reprocessed DePuy Mitek Ablation Wand | Renovo, Inc. | 2018-03-19 |
| K173741 | Reprocessed ArthoCare Ablation Wand | Renovo, Inc. | 2018-03-05 |
| K172647 | Reprocessed ArthroCare ENT Coblator | Renovo, Inc. | 2018-02-21 |
| K172608 | Medline ReNewal Reprocessed Stryker SERF AS Energy Probes | Surgical Instrument Service and Savings, Inc. | 2017-10-18 |
| K171324 | Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics | Surgical Instrument Service and Savings, Inc. | 2017-06-23 |
| K162751 | Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider | Surgical Instrument Services and Savings, Inc. | 2017-05-01 |
Legacy Summary#
summary
FDA Review#
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