510(k) Report

510(k) · Cleared

Cleared

Reprocessed Ethicon Ets Endoscopic Linear Cutters

K070859510(k) TraditionalCleared Sep 12, 2007168-day reviewClass II21 CFR 878.4750

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sterilmed, Inc. · NLL Staple, Implantable, Reprocessed

Cleared on Sep 12, 2007 as substantially equivalent to K961390 (Ethicon Endo-Surgery, Inc., 1996) and 3 other predicates after a 168-day review. Its family tree reaches back 3 generations to 1982.

Decided
Sep 12, 2007
Review
168 days
Class
Class II
Product code
NLL
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K821994 (1982). 17 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestor1996: 2 other ancestors1998: 1 other ancestor1997: 1 other ancestor1995: 2 other ancestors1994: 3 other ancestors1992: 1 other ancestor1991: 1 other ancestor1989: 1 other ancestor1984: 1 other ancestorK821994 · Disposable Linear Stapler-(LSR) · ETHICON, Inc. · 1982K980023 · Endopath and Proximate Linear Cutters · Ethicon Endo-Surgery, Inc. · 1998K020779 · Proximate and Endopath Linear Cutters and Staplers · Ethicon Endo-Surgery, Inc. · 2002 · recalled198019851990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 12 other ancestors K020779 · Proximate and Endopath Linear Cutters and Staplers · Ethicon Endo-Surgery, Inc. · 2002 · recalledK980023 · Endopath and Proximate Linear Cutters · Ethicon Endo-Surgery, Inc. · 1998K821994 · Disposable Linear Stapler-(LSR) · ETHICON, Inc. · 19820
  1. Root · 3 generations backK821994 Disposable Linear Stapler-(LSR)ETHICON, Inc. · 1982
  2. 2 generations backK980023 Endopath and Proximate Linear CuttersEthicon Endo-Surgery, Inc. · 1998
  3. 1 generation backK020779 Proximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc. · 2002 · Recalled
  4. This deviceK070859 Reprocessed Ethicon Ets Endoscopic Linear CuttersSterilmed, Inc. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K821994Disposable Linear Stapler-(LSR)ETHICON, Inc.1982—
−2K980023Endopath and Proximate Linear CuttersEthicon Endo-Surgery, Inc.1998—
−1K020779Proximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc.200217
0 (this device)K070859Reprocessed Ethicon Ets Endoscopic Linear CuttersSterilmed, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198910
199110
199210
199430
199520
199620
199710
199810
200010
FIG. 1 — Lineage of K070859, 1982–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NLL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K961390Endopath Ets Linear/Ets-Flex Articulating Linear Endoscopic Cutter
Summary page 1
…are substantially equivalent to the Ethicon Devices: Endopath ETS Endoscopic Linear Cutter and ETS-Flex Endoscopic Articulating Linear Cutter (K961390). Device SterilMed's reprocessed Ethicon ETS Linear Cutter is a sterile, single patient use Description: device…
Ethicon Endo-Surgery, Inc.19962
*K980023Endopath and Proximate Linear Cutters
Summary page 1
…substantially equivalent to the Endopath ETS Endoscopic Linear Cutter and ETS-Flex Endoscopic Articulating Linear Cutter (K961390, K980023, K002398 and K020079) manufactured by Ethicon. This conclusion is based upon the devices' similarities in func…
Ethicon Endo-Surgery, Inc.1998—
*K002398Endopath ETS45, Ets FLEX45, Ets Compact-FLEX45 Linear Cutters, Ets FLEX45 and Ets…
Summary page 1
…ially equivalent to the Endopath ETS Endoscopic Linear Cutter and ETS-Flex Endoscopic Articulating Linear Cutter (K961390, K980023, K002398 and K020079) manufactured by Ethicon. This conclusion is based upon the devices' similarities in functional de…
Ethicon Endo-Surgery, Inc.2000—
*K020779Proximate and Endopath Linear Cutters and Staplers
Our reading of the summary gave K020079, FDA’s number for Bladeworks Microkeratome Blade, Model 7061 (Blade Works, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Ethicon Endopath ETS Endoscopic Linear Cutter and ETS-Flex…”.
Ethicon Endo-Surgery, Inc.200217

Also cleared against K961390: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
  • 2 of the 17 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K961390.

How does its category compare?

All NLL devices

NLL Staple, Implantable, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · NLL

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NLL

Too few NLL 510(k)s in any year since 2007 to give a median.

Recalls per year · NLL

No recall names NLL since 2007.

Adverse event reports per year · NLL

2in 2017

2007: 12016: 12017: 2
2007high 2 (2017) · low 0 (2008)2025

MAUDE reports naming product code NLL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—01
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—01
20170—02
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The ETS 45, ETS-Flex45, and Compact-Flex 45 reprocessed, reloadable Endoscopic Linear Cutters are intended for transection, resection and/or anastomosis. These instruments have applications in open and minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic and pediatric surgery. The ETS Flex 45, ETS 45 and ETS Compact Flex 45 device can be used with staple line or tissue buttressing materials such as bovine pericardium.

The ETS and ETS-Flex (articulating) reprocessed, reloadable Endoscopic Linear Cutters (35mran) have applications in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.

Indications for use as stated in the FDA summary.

Also cleared against K961390

4 other devices cite the same predicate.

  • K150026Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear…Ethicon Endo-Surgery, LLC · 2015
  • K111111Endopath Ets 35MM Endoscopic Linear Cutter and Reloads, and Ets-Flex 35MM Endoscopic Articulating Linear…Ethicon Endo-Surgery, LLC · 20113 recalls
  • K020779Proximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc. · 200217 recalls
  • K980023Endopath and Proximate Linear CuttersEthicon Endo-Surgery, Inc. · 1998

More from Sterilmed, Inc.

65 FDA decisions under this applicant name. See the company

  • K254149Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825)…Sterilmed, Inc. · 2026
  • K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology CatheterSterilmed, Inc. · 2024
  • K190478Reprocessed ViewFlex™ Xtra ICE CatheterSterilmed, Inc. · 2019
  • K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc. · 2019
  • K182272Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisSterilmed, Inc. · 2019

Recent decisions in NLL

The NLL category page

  • K070930Reprocessed Autosuture Gia Endoscopic StaplersSterilmed, Inc. · 2007
  • K033578Reprocessed Reloadable Cutters, Staplers, and AppliersClearmedical, Inc. · 2005

https://510kreport.com/device/K070859 · printed Nov 5, 2026

Cite this page

510(k) Report. “K070859: Reprocessed Ethicon Ets Endoscopic Linear Cutters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070859

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026