510(k) Report

510(k) · Cleared

Cleared

Auto Suture Disposable Endoscopic Specimen Pouch

K922123510(k) TraditionalCleared Feb 1, 1993271-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

United States Surgical, A Division of Tyco Healthc · GCI Laryngoscope, Endoscope

Cleared on Feb 1, 1993 after a 271-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 74 later devices descend from it.

Decided
Feb 1, 1993
Review
271 days
Class
Class II
Product code
GCI
Recalls
None
Predicates
0

74 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2002: 2 descendants cleared2010: 2 descendants cleared2016: 5 descendants cleared2003: 3 descendants cleared2008: 2 descendants cleared2004: 1 descendant cleared2018: 4 descendants cleared2005: 1 descendant cleared2013: 3 descendants cleared2009: 2 descendants cleared2011: 4 descendants cleared2007: 1 descendant cleared2015: 2 descendants cleared2024: 7 descendants cleared2014: 5 descendants cleared2012: 2 descendants cleared2021: 4 descendants cleared2017: 3 descendants cleared2022: 2 descendants cleared2019: 2 descendants cleared2020: 3 descendants cleared2025: 8 descendants cleared2023: 3 descendants cleared2026: 3 descendants cleared1990200020102020
  1. This deviceK922123 Auto Suture Disposable Endoscopic Specimen PouchUnited States Surgical, A Division of Tyco Healthc · 1993
  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 74 descendants. See all descendants

Descendants cleared per year

2002: 22003: 32004: 12005: 12007: 12008: 22009: 22010: 22011: 42012: 22013: 32014: 52015: 22016: 52017: 32018: 42019: 22020: 32021: 42022: 22023: 32024: 72025: 82026: 3
2002high 8 (2025) · low 0 (2006)2026

Most influential descendants

Showing 5 of 74 · 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)K922123Auto Suture Disposable Endoscopic Specimen PouchUnited States Surgical, A Division of Tyco Healthc1993—
+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
200220
200330
200410
200510
200710
200820
200920
201020
201140
201220
201330
201450
201520
201650
201730
201840
201920
202030
202140
202220
202330
202470
202580
202630
FIG. 1 — Lineage of K922123, 1993–2026Source: 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 GCI? 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?

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

What descends from it? (74)

See all 74

6 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
K020047Rubicor Breast Biopsy DeviceRubicor Medical, Inc.20025
K030422Lina-Bag, Models LB-60, LB-100Lina Medical Cml Aps20033
K162059Ezee RetrievalGenicon, Inc.20161
K163102ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mmCovidien20160
K092821Tissuebag, Models: A10 211, A10 212, Tbi 100, TBI1011, TBI1021Agency For Medical Innovations, Inc.20100

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 GCI devices

GCI Laryngoscope, Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCI

FDA has decided no GCI device since 2007.

Median 510(k) review, days · GCI

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

Recalls per year · GCI

No recall names GCI since 2007.

Adverse event reports per year · GCI

121in 2025

2007: 12008: 22009: 72010: 192011: 492012: 552013: 502014: 1062015: 1772016: 1002017: 1302018: 1022019: 1352020: 1292021: 962022: 1022023: 1012024: 1192025: 121
2007high 177 (2015) · low 1 (2007)2025

MAUDE reports naming product code GCI, 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
20070—01
20080—02
20090—07
20100—019
20110—049
20120—055
20130—050
20140—0106
20150—0177
20160—0100
20170—0130
20180—0102
20190—0135
20200—0129
20210—096
20220—0102
20230—0101
20240—0119
20250—0121
20260—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 GCI

The GCI category page

  • K021747Degall Laparoscopic Gallbladder ExtractorSurgicon, Inc. · 2002
  • K003222Modification to Hermes Operating Room Control CenterComputer Motion, Inc. · 2000
  • K001362Karl Storz 3D Video SystemKarl Storz Imaging, Inc. · 2000
  • K930302Birtcher Sure Clean Instrument SystemBirtcher Medical Systems, Inc. · 1993
  • K933515Booty Endoscope WarmerT-Med, Inc. · 1993

https://510kreport.com/device/K922123 · printed Nov 6, 2026

Cite this page

510(k) Report. “K922123: Auto Suture Disposable Endoscopic Specimen Pouch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922123

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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