Data / Medical devices / Peru / Biogenomics S.A.C. - Biocells Surgical
Biogenomics S.A.C. - Biocells Surgical: FDA-registered device maker in Lima Lima(Province), Peru, 51 510(k) clearances
Biogenomics S.A.C. - Biocells Surgical is registered with the FDA (registration 3021393544) in Lima Lima(Province), Peru. It lists 32 device types. The FDA files 51 510(k) clearances under its listings, the newest dated July 25, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3021393544
- Address
- Av. Guardia Civil 1321, Office 1303, Lima Lima(Province), Peru, 15036
- Owner or operator
- Biogenomics S.A.C. - Biocells Surgical (10084035)
- Roles
- Exporter to the US
- First device listed
- January 11, 2022
- Registered through
- 2026
- Brand names listed
- Accessories, Photographic, For Endoscope (Exclude Light Sources), Apparatus, traction, non-powered, Bit, Drill, Blade, Saw, General & Plastic Surgery, Surgical, CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO, COMPONENT, TRACTION, NON-INVASIVE, Camera, Surgical And Accessories, INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 25, 2024 | K241361 | Arthrex Synergy Vision Endoscopic Imaging System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 15, 2023 | K232973 | Arthrex Knee FiberTak® Button Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 3, 2023 | K232742 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 1, 2023 | K231330 | FiberTak® Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 18, 2023 | K231113 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 24, 2023 | K223759 | Arthrex SynergyID Endoscopic Imaging System | GCJ | Substantially Equivalent | Arthex, Inc. | accessdata.fda.gov |
| December 22, 2022 | K221396 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 11, 2022 | K222161 | Arthrex Knotless FiberTak Biceps Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 25, 2021 | K212146 | Arthrex LoopLoc Knotless Suture | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 19, 2021 | K203495 | Arthrex SwiveLock Anchor | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 27, 2020 | K203268 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 18, 2020 | K202535 | Arthrex FastThread Interference Screw | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 4, 2020 | K202581 | Arthrex TightRope II | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 4, 2020 | K201134 | Arthrex NanoScope System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 12, 2020 | K200341 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 26, 2019 | K191426 | FiberTak Button | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 19, 2019 | K190125 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire | MBI | Substantially Equivalent | T.A.G. Medical Products Corporation, Ltd. | accessdata.fda.gov |
| September 21, 2018 | K181769 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 22, 2018 | K180594 | Knotless SutureTak Anchors | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 28, 2017 | K172612 | FiberTak DX | MBI | Substantially Equivalent | Arthex, Inc. | accessdata.fda.gov |
| May 26, 2017 | K171296 | SutureTape | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 9, 2016 | K161581 | Arthrex Synergy RF System | GEI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 12, 2016 | K153218 | Arthrex Synergy UHD4 System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 19, 2015 | K151230 | Arthrex FiberTak Anchors | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 3, 2015 | K143749 | Arthrex Distal Radius System | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 18, 2014 | K140855 | ARTHREX SUTURETAK SUTURE ANCHORS | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 30, 2014 | K133275 | MINI TIGHTROPE | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 31, 2013 | K132043 | ARTHREX SPEEDCINCH | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 3, 2013 | K130458 | KNOTLESS FIBERTAK SUTURE ANCHOR | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 25, 2012 | K122374 | ARTHREX SUTURE (UHMWPE) | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 19, 2011 | K112990 | ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 28, 2011 | K110123 | PCL TIGHTROPE | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 31, 2011 | K110660 | ARTHREX BIOCOMPOSITE SUTURETAK | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 7, 2011 | K101823 | ARTHREX SWIVELOCK ANCHORS | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 22, 2010 | K101679 | ARTHREX PUSHLOCK ANCHORS | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 28, 2009 | K091844 | ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 3, 2009 | K083707 | ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE | HRX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 23, 2009 | K082810 | ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 18, 2008 | K080560 | HENKE SASS WOLF OF AMERICA ARTHROSCOPE | HRX | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
| February 11, 2008 | K073149 | MENISCAL CINCH | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 3, 2007 | K071176 | MODIFICATION TO: ARTHREX INTERFERENCE SCREW | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 29, 2006 | K062466 | ARTHREX INTERFERENCE SCREW | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 19, 2006 | K061863 | ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 13, 2005 | K052776 | TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 16, 2005 | K043248 | TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 8, 2004 | K041965 | ARTHREX HUMERAL FRACTURE PLATES AND SCREWS | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 20, 2003 | K024291 | ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475 | HRX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 17, 2002 | K023986 | ARTHREX OPES ELECTRODES AND ACCESSORIES | GEI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 16, 1994 | K941541 | HSV LAPAROSCOPY SET | GCJ | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
| January 25, 1994 | K932699 | ARTHREX AR-8200 SHAVER SYSTEM | HWE | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 23, 1990 | K901035 | FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE | FST | Substantially Equivalent | Cuda Products Co. | accessdata.fda.gov |
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Updated July 25, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.