510(k) Report

510(k) · Cleared

Cleared

Reprocessed Endoscopic Trocars

K111002510(k) TraditionalCleared Jul 18, 201198-day reviewClass II21 CFR 876.1500

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

Sterilmed, Inc. · NLM Laparoscope, General & Plastic Surgery, Reprocessed

Cleared on Jul 18, 2011 as substantially equivalent to K072674 (Applied Medical Resources Corp., 2007) and 5 other predicates after a 98-day review. Its family tree reaches back 4 generations to 1999.

Decided
Jul 18, 2011
Review
98 days
Class
Class II
Product code
NLM
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K990028 (1999). 11 ancestors in all, the oldest K932995 (1993). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor2002: 1 other ancestor2001: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor1994: 1 other ancestor1993: 1 other ancestorK990028 · Endopath Optiview Optical Surgical Obturator and Sleeve · Ethicon Endo-Surgery, Inc. · 1999K032889 · Optical Separator · Applied Medical Resources · 2003K060096 · Modular Trocar System · Applied Medical Resources Corp. · 2006 · recalledK072674 · Kii Trocar System · Applied Medical Resources Corp. · 2007 · recalled19901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 4 other ancestors K072674 · Kii Trocar System · Applied Medical Resources Corp. · 2007 · recalledK060096 · Modular Trocar System · Applied Medical Resources Corp. · 2006 · recalledK032889 · Optical Separator · Applied Medical Resources · 2003K990028 · Endopath Optiview Optical Surgical Obturator and Sleeve · Ethicon Endo-Surgery, Inc. · 19990
  1. Root · 4 generations backK990028 Endopath Optiview Optical Surgical Obturator and SleeveEthicon Endo-Surgery, Inc. · 1999
  2. 3 generations backK032889 Optical SeparatorApplied Medical Resources · 2003
  3. 2 generations backK060096 Modular Trocar SystemApplied Medical Resources Corp. · 2006 · Recalled
  4. 1 generation backK072674 Kii Trocar SystemApplied Medical Resources Corp. · 2007 · Recalled
  5. This deviceK111002 Reprocessed Endoscopic TrocarsSterilmed, Inc. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K990028Endopath Optiview Optical Surgical Obturator and SleeveEthicon Endo-Surgery, Inc.1999—
−3K032889Optical SeparatorApplied Medical Resources2003—
−2K060096Modular Trocar SystemApplied Medical Resources Corp.20067
−1K072674Kii Trocar SystemApplied Medical Resources Corp.20072
0 (this device)K111002Reprocessed Endoscopic TrocarsSterilmed, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199410
199610
199710
200110
200210
200410
FIG. 1 — Lineage of K111002, 1999–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Top candidate predicates for a new NLM device

  1. #1 K201511 Reprocessed Endoscopic Trocars and Sleevesscore -1.9 · 2 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (6)

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
*K072674Kii Trocar System
Summary page 1
…NLM Pr-edicate The reprocessed endoscopic trocars are Substantially equivalent to the Applied Medical trocars Devices: (5 10(k)s 1(072674, 1(060096,1(041795,1(032889, K(012884, & 1(012968). D5ev-ice The reprocessed endoscopic trocar is a sterile instrum…
Applied Medical Resources Corp.20072
*K060096Modular Trocar System
Summary page 1
…NLM Pr-edicate The reprocessed endoscopic trocars are Substantially equivalent to the Applied Medical trocars Devices: (5 10(k)s 1(072674, 1(060096,1(041795,1(032889, K(012884, & 1(012968). D5ev-ice The reprocessed endoscopic trocar is a sterile instrument consis…
Applied Medical Resources Corp.20067
*K041795Modification to Optical Separator System
Summary page 1
…r-edicate The reprocessed endoscopic trocars are Substantially equivalent to the Applied Medical trocars Devices: (5 10(k)s 1(072674, 1(060096,1(041795,1(032889, K(012884, & 1(012968). D5ev-ice The reprocessed endoscopic trocar is a sterile instrument consisting of a…
Applied Medical Resources Corp.20041
*K032889Optical Separator
Summary page 1
…The reprocessed endoscopic trocars are Substantially equivalent to the Applied Medical trocars Devices: (5 10(k)s 1(072674, 1(060096,1(041795,1(032889, K(012884, & 1(012968). D5ev-ice The reprocessed endoscopic trocar is a sterile instrument consisting of a sleeve a…
Applied Medical Resources2003—
*K012884Dilating Tip Obturator
Summary page 1
…The reprocessed endoscopic trocars are Substantially equivalent to the Applied Medical trocars Devices: (5 10(k)s 1(072674, 1(060096,1(041795,1(032889, K(012884, & 1(012968). D5ev-ice The reprocessed endoscopic trocar is a sterile instrument consisting of a sleeve and obturat…
Applied Medical Resources Corp.20027
*K012968Applied Access Seal
Summary page 1
…essed endoscopic trocars are Substantially equivalent to the Applied Medical trocars Devices: (5 10(k)s 1(072674, 1(060096,1(041795,1(032889, K(012884, & 1(012968). D5ev-ice The reprocessed endoscopic trocar is a sterile instrument consisting of a sleeve and obturator Descript…
Applied Medical Resources Corp.2001—

Also cleared against K072674: 1 other device →

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 12 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
  • 4 of the 11 ancestors have a recall of any class.
  • 1 other device also cites its predicate K072674.

How does its category compare?

All NLM devices

NLM Laparoscope, General & Plastic Surgery, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · NLM

1in 2020

2007: 42010: 12011: 12012: 12013: 12014: 12016: 22017: 22019: 12020: 1
2007high 4 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NLM

284in 2007

2007: 284 days median
2007high 284 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NLM

6so far in 2026, the most since 2007

2008: 12010: 12016: 12018: 12026 (partial year): 6
2007high 6 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NLM

10in 2025

2007: 22008: 12009: 22010: 112011: 72012: 822013: 1022014: 842015: 272016: 392017: 152018: 92019: 62020: 12021: 52022: 52023: 52024: 42025: 10
2007high 102 (2013) · low 1 (2008)2025

MAUDE reports naming product code NLM, 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
2007428402
20080—11
20090—02
20101—111
20111—07
20121—082
20131—0102
20141—084
20150—027
20162—139
20172—015
20180—19
20191—06
20201—01
20210—05
20220—05
20230—05
20240—04
20250—010
20260—6—

What is it indicated for?

The reprocessed endoscopic trocars; are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures.

Indications for use as stated in the FDA summary.

Also cleared against K072674

1 other device cites the same predicate.

  • K231400Bladeless Trocar – Artemis Lap CannulaT.A.G. Medical Products Corporation, Ltd. · 2023

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 NLM

The NLM category page

  • K201511Reprocessed Endoscopic Trocars and SleevesStryker Sustainability Solutions · 20206 recalls
  • K182828Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture PasserSurgical Instrument Service and Savings, Inc. · 2019
  • K172097Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar SleevesRenovo, Inc. · 2017
  • K172093Reprocessed Covidien TrocarRenovo, Inc. · 2017
  • K160740Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW TechnologySurgical Instrument Service and Savings, Inc. · 2016

https://510kreport.com/device/K111002 · printed Nov 4, 2026

Cite this page

510(k) Report. “K111002: Reprocessed Endoscopic Trocars.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111002

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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