510(k) Report

510(k) · Cleared

Cleared

Auto Suture Disp. Endoscopic Surg. Clip Applier

K883018510(k) TraditionalCleared Aug 3, 198815-day reviewClass II21 CFR 878.4300

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

United States Surgical, A Division of Tyco Healthc · FZP Clip, Implantable

Cleared on Aug 3, 1988 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 69 later devices descend from it.

Decided
Aug 3, 1988
Review
15 days
Class
Class II
Product code
FZP
Recalls
None
Predicates
0

69 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2010: 2 descendants cleared2015: 3 descendants cleared2006: 1 descendant cleared2008: 2 descendants cleared2007: 1 descendant cleared2024: 8 descendants cleared2012: 3 descendants cleared2009: 2 descendants cleared2011: 4 descendants cleared2016: 3 descendants cleared2013: 2 descendants cleared2014: 5 descendants cleared2022: 3 descendants cleared2017: 3 descendants cleared2018: 3 descendants cleared2025: 10 descendants cleared2019: 2 descendants cleared2020: 3 descendants cleared2023: 3 descendants cleared2026: 3 descendants cleared2021: 3 descendants cleared1990200020102020
  1. This deviceK883018 Auto Suture Disp. Endoscopic Surg. Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1988
  2. Descendant · cites it directly · 59 of its ownK072814 Convenience Kit for Single-Incision Laparoscopic Surgery and Other…Covidien · 2008
  3. Descendant · 2 generations on · 58 of its ownK082619 Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008
  4. Descendant · 3 generations on · 46 of its ownK090902 Spider Single Port Surgical Device, Support Arm Accessory, Model…Transenterix, Inc. · 2009 · Recalled
  5. Descendant · 3 generations on · 43 of its ownK112208 Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2011 · Recalled
  6. Descendant · 4 generations on · 42 of its ownK120215 Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper…Intuitive Surgical, Inc. · 2012 · Recalled

Showing 5 of 69 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12008: 22009: 22010: 22011: 42012: 32013: 22014: 52015: 32016: 32017: 32018: 32019: 22020: 32021: 32022: 32023: 32024: 82025: 102026: 3
2006high 10 (2025) · low 1 (2006)2026

Most influential descendants

Showing 5 of 69 · See all
  • K072814Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic…Covidien · 2008 · cites it directly59descendants
  • K082619Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008 · 2 generations on58descendants
  • K090902Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002, 90003Transenterix, Inc. · 2009 · 3 generations on46descendants
  • K112208Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2011 · 3 generations on43descendants
  • K120215Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper, Single-Site Fundus…Intuitive Surgical, Inc. · 2012 · 4 generations on42descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K883018Auto Suture Disp. Endoscopic Surg. Clip ApplierUnited States Surgical, A Division of Tyco Healthc1988—
+1K072814Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced…Covidien2008—
+2K082619Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States2008—
+3K090902Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002…Transenterix, Inc.20091
+3K112208Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc.201112
+4K120215Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper…Intuitive Surgical, Inc.20123

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
200820
200920
201020
201140
201230
201320
201450
201530
201630
201730
201830
201920
202030
202130
202230
202330
202480
2025100
202630
FIG. 1 — Lineage of K883018, 1988–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FZP? 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 FZP device

  1. #1 K260677 Vessel Closure Device (VCD177213P)score 12.6 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (69)

See all 69

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K072814Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic…Covidien200859
K061288Auto Suture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc20068
K143644Premium Surgiclip¿; Endo Clip¿; AcuClip¿Covidien20151
K100242Auto Suture Endo Clip III5MM Clip AdapterSurgical Devices, A Division of Tyco Healthcare20100

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?

  • Of its descendants, K072814 (Covidien, 2008) has gone furthest, with 59 descendants of its own.

How does its category compare?

All FZP devices

FZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FZP

5in 2025

2007: 62008: 42009: 32010: 62011: 32012: 22013: 32014: 32015: 82016: 52017: 42018: 42019: 12020: 22022: 32023: 32024: 22025: 52026 (partial year): 2
2007high 8 (2015) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FZP

90in 2025

2007: 31 days median2008: 23 days median2009: 22 days median2010: 47 days median2011: 124 days median2013: 47 days median2014: 29 days median2015: 182 days median2016: 72 days median2017: 29 days median2018: 143 days median2022: 227 days median2023: 65 days median2025: 90 days median
2007high 227 (2022) · low 22 (2009)2026

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

Recalls per year · FZP

1in 2020

2007: 12008: 62010: 12012: 12014: 12016: 22017: 12019: 32020: 1
2007high 6 (2008) · low 0 (2009)2026

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

Adverse event reports per year · FZP

1,902in 2025

2007: 1,8772008: 9812009: 2,1602010: 2,3672011: 1,6782012: 1,6772013: 2,3812014: 2,3202015: 2,8712016: 1,8402017: 2,5942018: 2,7182019: 2,9032020: 1,7602021: 1,7592022: 1,5752023: 1,9182024: 2,0672025: 1,902
2007high 2,903 (2019) · low 981 (2008)2025

MAUDE reports naming product code FZP, 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
200763111,877
20084236981
200932202,160
201064712,367
2011312401,678
20122—11,677
201334702,381
201432912,320
2015818202,871
201657221,840
201742912,594
2018414302,718
20191—32,903
20202—11,760
20210—01,759
2022322701,575
202336501,918
20242—02,067
202559001,902
20262—0—

More from United States Surgical, A Division of…

218 FDA decisions under this applicant name. See the company

  • K071406Autosuture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2007
  • K071920Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc · 2007
  • K061288Auto Suture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062850Autosuture Circular Eea Surgical StaplersUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062326Autosuture Modified Versaport Trocar with Fixation SleeveUnited States Surgical, A Division of Tyco Healthc · 2006

Recent decisions in FZP

The FZP category page

  • K260677Vessel Closure Device (VCD177213P)Vcd Medical S.R.L. · 2026
  • K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical Corporation · 2026
  • K253903InnoClip Disposable Clip ApplierTaiwan Surgical Corporation · 2025
  • K253781InnoClip Clip ApplierTaiwan Surgical Corporation · 2025
  • K250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd. · 2025

https://510kreport.com/device/K883018 · printed Nov 6, 2026

Cite this page

510(k) Report. “K883018: Auto Suture Disp. Endoscopic Surg. Clip Applier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K883018

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026