510(k) · Cleared

Cleared

DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)

K200053510(k) TraditionalCleared Apr 21, 2020102-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

Dannik · GCJ Laparoscope, General & Plastic Surgery

Cleared on Apr 21, 2020 as substantially equivalent to K111845 (Espiner Medical Limited, 2011) after a 102-day review. Its family tree reaches back 2 generations to 1998.

Decided: Apr 21, 2020
Review: 102 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K982073 (1998). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK982073 Anchor Laparoscopic Tissue Retrieval SystemAnchor Products Co. · 1998
1 generation backK111845 The Espiner Sac or E SacEspiner Medical Limited · 2011 · Recalled
This deviceK200053 DANNIK Specimen Retrieval System with deployment mechanism, DANNIK…Dannik · 2020

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K982073	Anchor Laparoscopic Tissue Retrieval System	Anchor Products Co.	1998	—
−1	K111845	The Espiner Sac or E Sac	Espiner Medical Limited	2011	1
0 (this device)	K200053	DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen…	Dannik	2020	—

FIG. 1 — Lineage of K200053, 1998–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K111845	The Espiner Sac or E Sac Summary page 4 …astic Surgery 3. Substantially Equivalent Device • Legally Marketed (Unmodified Devices): o The Espiner Tissue Retrieval System o 510(k) K111845 4. Description The DANNIK Specimen Retrieval System are sterile single patient use devices, which comprise of a flexible p…	Espiner Medical Limited	2011	1

Also cleared against K111845: 4 other devices →

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 22 years and passes through 3 companies; a new generation was cleared every 13.0 years on median.
1 of the 2 ancestors has a recall of any class.
4 other devices also cite its predicate K111845.

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. 2020, this device’s year, is highlighted.

FDA decisions per year · GCJ

21in 2025

2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007high 122 (2010) · low 42 (2007)2026

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

Recalls per year · GCJ

5in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	18	42	12	1,639
2008	19	73	16	1,319
2009	21	85	6	1,995
2010	24	122	30	2,657
2011	15	113	9	2,133
2012	17	88	1	1,526
2013	15	93	7 (1)	1,565
2014	19	90	2	1,714
2015	26	76	0	1,710
2016	27	99	5	2,080
2017	20	77	1	3,468
2018	21	88	1	2,562
2019	15	60	0	2,578
2020	28	61	0	2,618
2021	18	116	0	3,431
2022	20	103	1	3,945
2023	31	109	1	6,002
2024	29	90	0	6,047
2025	21	108	5	5,860
2026	26	122	1	—

What is it indicated for?

The DANNIK Specimen Retrieval System is indicated for use in surgical procedures to capture organs or tissue to be removed from the body cavity during Laparoscopic Surgery via extracorporeal manual morcellation.

The DANNIK Specimen Retrieval System is contraindicated for laparoscopic power morcellation during gynecologic procedures. The DANNIK Specimen Retrieval System is contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to the best interest of the patient.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K200053 · printed Nov 6, 2026

Cite this page

510(k) Report. “K200053: DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200053

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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