510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

Reprocessed Endoscopic Trocars and Cannulas

K063788510(k) TraditionalCleared Oct 15, 2007298-day reviewClass II21 CFR 876.1500Recalls 3

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

Ascent Healthcare Solutions · NLM Laparoscope, General & Plastic Surgery, Reprocessed

Cleared on Oct 15, 2007 as substantially equivalent to K041795 (Applied Medical Resources Corp., 2004) and 3 other predicates after a 298-day review. Its family tree reaches back 3 generations to 1999. It has been recalled 3 times.

Decided
Oct 15, 2007
Review
298 days
Class
Class II
Product code
NLM
Recalls
3
Predicates
4

Its longest line of descent runs back 3 generations to K990028 (1999). 7 ancestors in all, the oldest K932995 (1993). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor2001: 1 other ancestor1996: 1 other ancestor1993: 1 other ancestorK990028 · Endopath Optiview Optical Surgical Obturator and Sleeve · Ethicon Endo-Surgery, Inc. · 1999K032889 · Optical Separator · Applied Medical Resources · 2003K041795 · Modification to Optical Separator System · Applied Medical Resources Corp. · 2004 · recalled1990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors K041795 · Modification to Optical Separator System · Applied Medical Resources Corp. · 2004 · recalledK032889 · Optical Separator · Applied Medical Resources · 2003K990028 · Endopath Optiview Optical Surgical Obturator and Sleeve · Ethicon Endo-Surgery, Inc. · 19990
  1. Root · 3 generations backK990028 Endopath Optiview Optical Surgical Obturator and SleeveEthicon Endo-Surgery, Inc. · 1999
  2. 2 generations backK032889 Optical SeparatorApplied Medical Resources · 2003
  3. 1 generation backK041795 Modification to Optical Separator SystemApplied Medical Resources Corp. · 2004 · Recalled
  4. This deviceK063788 Reprocessed Endoscopic Trocars and CannulasAscent Healthcare Solutions · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K990028Endopath Optiview Optical Surgical Obturator and SleeveEthicon Endo-Surgery, Inc.1999—
−2K032889Optical SeparatorApplied Medical Resources2003—
−1K041795Modification to Optical Separator SystemApplied Medical Resources Corp.20041
0 (this device)K063788Reprocessed Endoscopic Trocars and CannulasAscent Healthcare Solutions2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199610
200110
200210
FIG. 1 — Lineage of K063788, 1999–2007Source: 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 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? (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
*K041795Modification to Optical Separator System
Summary page 1
…lassification Name: Laparoscope, general & plastic surgery, reprocessed Predicate Device 510(k) Title Manufacturer K041795 Modification to Optical Separator Applied Medical K032889 Optical Separator A…
Applied Medical Resources Corp.20041
*K032889Optical Separator
Summary page 1
…reprocessed Predicate Device 510(k) Title Manufacturer K041795 Modification to Optical Separator Applied Medical K032889 Optical Separator Applied Medical K012884 Dilating Tip Obturator A…
Applied Medical Resources2003—
*K012884Dilating Tip Obturator
Summary page 1
…Manufacturer K041795 Modification to Optical Separator Applied Medical K032889 Optical Separator Applied Medical K012884 Dilating Tip Obturator Applied Medical K012968 Trocar Seal A…
Applied Medical Resources Corp.20027
*K012968Applied Access Seal
Summary page 1
…Applied Medical K032889 Optical Separator Applied Medical K012884 Dilating Tip Obturator Applied Medical K012968 Trocar Seal Applied Medical Device description: Reprocessed Endoscopic Trocars and C…
Applied Medical Resources Corp.2001—

Also cleared against K041795: 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)

Recalls of this device

DateClassRecallRoot causeReason
Jun 1, 2015Class IIZ-1836-2015Under Investigation by firmStryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.
Jun 1, 2015Class IIZ-1835-2015Under Investigation by firmStryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.
Jun 1, 2015Class IIZ-1834-2015Under Investigation by firmStryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
  • 2 of the 7 ancestors have a recall of any class.
  • 1 other device also cites its predicate K041795.

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. 2007, 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?

Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.

Indications for use as stated in the FDA summary.

Also cleared against K041795

1 other device cites the same predicate.

  • K111002Reprocessed Endoscopic TrocarsSterilmed, Inc. · 2011

More from Ascent Healthcare Solutions

21 FDA decisions under this applicant name. See the company

  • K111600Reprocessed Hand Activate Sealer/DividerAscent Healthcare Solutions · 2011
  • K110189Reprocessed Electrosurgical InstrumentAscent Healthcare Solutions · 2011
  • K100909Reprocessed Compression SleevesAscent Healthcare Solutions · 20101 recall
  • K100254Reprocessed CS BI-Diectional Diagnostic Electrophysiology CatheterAscent Healthcare Solutions · 201027 recalls
  • K100537Reprocessed Ultrasonic Curved Shears with Torque Wrench and Grip Assist Model FCS9, Twblue, GablueAscent Healthcare Solutions · 2010

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/K063788 · printed Nov 5, 2026

Cite this page

510(k) Report. “K063788: Reprocessed Endoscopic Trocars and Cannulas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063788

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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