Atlas FDA

NLM

23 FDA 510(k) clearances · Product code

131 daysmedian time to decision
298 days90th percentile
23clearances measured

FDA profile

Official device name
Laparoscope, General & Plastic Surgery, Reprocessed
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
FDA definition
The "Endoscope and accessories, reprocessed" is intended to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Adverse events (MAUDE)
2013: 102 · 2014: 84 · 2015: 27 · 2016: 39 · 2017: 15 · 2026: 44
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Reprocessed Endoscopic Trocars and Sleeves (K201511)Stryker Sustainability Solutions2020-07-31
Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer (K182828)Surgical Instrument Service and Savings, Inc.2019-04-15
Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves (K172097)Renovo, Inc.2017-10-06
Reprocessed Covidien Trocar (K172093)Renovo, Inc.2017-10-05
Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology (K160740)Surgical Instrument Service and Savings, Inc.2016-05-06
Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars (K153258)Surgical Instrument Service and Savings (Dba Medline Renewal2016-04-05
REPROCESSED CLOSURE SYSTEM (K133414)Sterilmed, Inc.2014-01-22
REPROCESSED DILATING TIP TROCARS (K132629)Stryker Sustainability Solutions2013-12-31
REPROCESSED ENDOSCOPIC TROCARS (K121240)Sterilmed, Inc.2012-06-11
REPROCESSED ENDOSCOPIC TROCARS (K111002)Sterilmed, Inc.2011-07-18
REPROCESSED TROCARS, MODEL B5LT AND CB5LT (K100080)Ascent Healthcare Solutions2010-03-19
REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS (K063788)Ascent Healthcare Solutions2007-10-15
REPROCESSED TROCARS (K070059)Ascent Healthcare Solutions2007-10-02
NES REPROCESSED ENDOSCOPIC TROCAR (K060676)Northeast Scientific, Inc.2007-09-07
REPROCESSED TROCARS (K062497)Ascent Healthcare Solutions2007-01-31
VANGUARD REPROCESSED SUTURE PASSER (K053585)Ascent Healthcare Solutions2006-10-11
REPROCESSED ENDOSCOPIC TROCAR (K052299)Sterilmed, Inc.2006-05-23
REPROCESSED ENDOSCOPIC TROCAR (K043592)Sterilmed, Inc.2005-05-23
VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS (K043253)Vanguard Medical Concepts, Inc.2005-04-08
VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES (K043594)Vanguard Medical Concepts, Inc.2005-03-31
REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS (K024015)Alliance Medical Corp.2003-03-04
REPROCESSED TROCARS AND CANNULAS (K012644)Surgical Instruments Service and Savings, Inc.2002-07-29
REPROCESSED ENDOSCOPIC TROCAR (K012578)Sterilmed, Inc.2001-11-07

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