510(k) Report

510(k) · Cleared

Cleared

Specimen Retrieval System

K100959510(k) TraditionalCleared Apr 22, 201015-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

Applied Medical Resources · GCJ Laparoscope, General & Plastic Surgery

Cleared on Apr 22, 2010 as substantially equivalent to K060051 (Applied Medical Resources Corp., 2006) after a 15-day review. Its family tree reaches back 1 generation to 2006. 7 later devices descend from it.

Decided
Apr 22, 2010
Review
15 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K060051 (2006). 7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2018: 1 descendant cleared2025: 1 descendant cleared2014: 1 descendant cleared2020: 1 descendant cleared2017: 1 descendant cleared2024: 1 descendant clearedK060051 · Specimen Retrieval System · Applied Medical Resources Corp. · 2006 · recalled20052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants K060051 · Specimen Retrieval System · Applied Medical Resources Corp. · 2006 · recalled0
  1. Root · 1 generation backK060051 Specimen Retrieval SystemApplied Medical Resources Corp. · 2006 · Recalled
  2. This deviceK100959 Specimen Retrieval SystemApplied Medical Resources · 2010
  3. Descendant · cites it directly · 3 of its ownK103510 Unimax Specimen Retrieval SystemUnimax Medical Systems, Inc. · 2011 · Recalled
  4. Descendant · cites it directly · 2 of its ownK172789 Specimen Retrieval BagBeijing Hangtian Kadi Technology R&D Institute · 2018
  5. Descendant · 2 generations on · 1 of its ownK201243 Disposable Specimen Retrieval BagBeijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2020
  6. Descendant · 2 generations on · 1 of its ownK141593 Unimicro Disposable Retrieval Endo-PouchUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2014
  7. Descendant · 2 generations on · 0 of its ownK250411 DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval SystemDannik, LLC · 2025

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2011: 12014: 12017: 12018: 12020: 12024: 12025: 1
2011high 1 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 7 · See all
  • K103510Unimax Specimen Retrieval SystemUnimax Medical Systems, Inc. · 2011 · cites it directly3descendants
  • K172789Specimen Retrieval BagBeijing Hangtian Kadi Technology R&D Institute · 2018 · cites it directly2descendants
  • K201243Disposable Specimen Retrieval BagBeijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2020 · 2 generations on1descendant
  • K141593Unimicro Disposable Retrieval Endo-PouchUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2014 · 2 generations on1descendant
  • K250411DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval SystemDannik, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K060051Specimen Retrieval SystemApplied Medical Resources Corp.20061
0 (this device)K100959Specimen Retrieval SystemApplied Medical Resources2010—
+1K103510Unimax Specimen Retrieval SystemUnimax Medical Systems, Inc.20111
+1K172789Specimen Retrieval BagBeijing Hangtian Kadi Technology R&D Institute2018—
+2K201243Disposable Specimen Retrieval BagBeijing Biosis Healing Biolog Ical Technology Co., Ltd.2020—
+2K141593Unimicro Disposable Retrieval Endo-PouchUnimicro Medical Systems (Shenzhen) Co., Ltd.2014—
+2K250411DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval SystemDannik, LLC2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201410
201710
201810
202010
202410
202510
FIG. 1 — Lineage of K100959, 2006–2025Source: 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 GCJ? 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 GCJ device

  1. #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 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? (1)

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
*K060051Specimen Retrieval System
Summary page 2
…INICAL TESTS SUBMITTED: Applied Medical created a dedicated test method designed to confirm safety and efficacy of the subject device relative to the predicate device of K06005 1. These tests focused on functionality, robustness and bag strength. Test results for predicate and new device are essentially the…
Applied Medical Resources Corp.20061

Also cleared against K060051: 3 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K103510Unimax Specimen Retrieval SystemUnimax Medical Systems, Inc.20113
K172789Specimen Retrieval BagBeijing Hangtian Kadi Technology R&D Institute20182

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?

  • Its one ancestor has a recall.
  • Of its descendants, K103510 (Unimax Medical Systems, Inc., 2011) has gone furthest, with 3 descendants of its own.
  • 3 other devices also cite its predicate K060051.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · GCJ

21in 2025

2007: 182008: 192009: 212010: 242011: 152012: 172013: 152014: 192015: 262016: 272017: 202018: 212019: 152020: 282021: 182022: 202023: 312024: 292025: 212026 (partial year): 26
2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007: 42 days median2008: 73 days median2009: 85 days median2010: 122 days median2011: 113 days median2012: 88 days median2013: 93 days median2014: 90 days median2015: 76 days median2016: 99 days median2017: 77 days median2018: 88 days median2019: 60 days median2020: 61 days median2021: 116 days median2022: 103 days median2023: 109 days median2024: 90 days median2025: 108 days median2026 (partial year): 122 days median
2007high 122 (2010) · low 42 (2007)2026

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

Recalls per year · GCJ

5in 2025

2007: 122008: 162009: 62010: 302011: 92012: 12013: 7, 1 Class I2014: 22016: 52017: 12018: 12022: 12023: 12025: 52026 (partial year): 1
2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007: 1,6392008: 1,3192009: 1,9952010: 2,6572011: 2,1332012: 1,5262013: 1,5652014: 1,7142015: 1,7102016: 2,0802017: 3,4682018: 2,5622019: 2,5782020: 2,6182021: 3,4312022: 3,9452023: 6,0022024: 6,0472025: 5,860
2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, 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
20071842121,639
20081973161,319
2009218561,995
201024122302,657
20111511392,133
2012178811,526
201315937 (1)1,565
2014199021,714
2015267601,710
2016279952,080
2017207713,468
2018218812,562
2019156002,578
2020286102,618
20211811603,431
20222010313,945
20233110916,002
2024299006,047
20252110855,860
2026261221—

What is it indicated for?

The Applied Medical Specimen Retrieval System is indicated for use

as a receptacle for the collection and extraction of tissue, organs and calculi during general

and laparoscopic surgical procedures.

Indications for use as stated in the FDA summary.

Also cleared against K060051

3 other devices cite the same predicate.

  • K232880Inzii Ripstop Redeployable Retrieval SystemApplied Medical Resources Corporation · 2023
  • K150781Tissue Removal PouchBoehringer Laboratories, LLC · 2015
  • K142427Tissue Containment System; 10, 14, 17, 25Applied Medical Resources · 2014

More from Applied Medical Resources

58 FDA decisions under this applicant name. See the company

  • K200021Applied Medical AnoscopeApplied Medical Resources · 2021
  • K162676Voyant Open Fusion DeviceApplied Medical Resources · 2016
  • K153017Voyant Fine FusionApplied Medical Resources · 2016
  • K153288Voyant Open Fusion DeviceApplied Medical Resources · 2016
  • K151480Epix Electrosurgical Probe with Smoke EvacuationApplied Medical Resources · 2016

Recent decisions in GCJ

The GCJ category page

  • K262455da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci…Intuitive Surgical, Inc. · 2026
  • K262397CuratOR EX2742Eizo Corporation · 2026
  • K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
  • K260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony Corporation · 2026
  • K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC · 2026

https://510kreport.com/device/K100959 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100959: Specimen Retrieval System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100959

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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